U.S.

Food & Orug:Admlnlstratlon·

10~0~.New Ha'ii1ps111t~Avenue
si1ve1 Spri11g, MD 20993 ·
wwv1.lda.gov

Q~RTlf:ICATE TO FO~~IGt:,J _G_QVERNMENT

- ·, .·',\,:~(d~r to·_§l~9W _the importation of United States products into foreign countries , _the u:s.-Food· and-D~ug _· -
: · A_dmir)lstratio11 ·(FDA) certifies the following information concerning the prodµct(s) to be exported Hsted b~low:
., .. ..,. . ~ '•. ,... . . .. , . ~- - . _,.,. - -· ~

: /:·,, ~ -J~lfme,·ou'ro~ubi~}:: -._ Name ofMaJlll~~,t~ter/Distrihiltor; Ad_c:lre~~.

,.>>·-~eiA~ch~d:L;L;f. . ..
. .. . ··•,.. '.'. . . . , ..
, See Attach~d List

·/ ·>· ·_(P.vb -~ig~t{-; ': :_: · ·: __,.,

• • • • -:,., - • • • ~ ....- - ·, • .,,. ,J, • • J" ••
. _, _.
: ,.
(One P~ge)

~: , ,·, ;Tile, ptQ~UG.t(sJ.deserioed'ab:Ov,e (and the manufacturing/distribution site(s) which produces/dtstributes it)Js,sobJ~fa , . ', _:- . . ' '•
. · · ·t9 the.juri~diotion ohhe.FPA.un.der the Federal Food, Drug, and Cosmetic Act. ·· · ·. · . , . ·,,: · · ·

'\.>iir;:dertitietlJhat:t~~ aboV~; pr~duct{s) may be marketed in' and legally exported frorn; th~: unit~d States oi_;,: ~- -~-. -
.<:-~Arn~r:i_ca'.~ttni~dinis; The manufacturing. plarit(s} .in whic:h. the product(s) is produ:ced is suotecqo:perioaiq:. -·. · · _· -~- ' ·
· :_' - [n$p_ectitm's.·rtie last;suc.h lnspection showed that the plant(s). at that time, appeared to be in ·substantial · · ·, ·· _- _._.,
,.:7 cqm_pli~nife·wi~h ·.G..Un'_~nt·good ma_nufacturing practice requi ren:ients for the product(s) .listed abqve. _ . - . ·, , ,
- .,_ .,-··-.._.._.:_-.-~ - ..
,- ..:.:. .::.·.::- ·.. -- -.... ,~ ,, ~.' ; '. ,
~--~~- -

· Slnce(ely; _ ____ __ _ __ _ : , . . ·
c_ab~---~-_--;-·:-::·/_ : ~:~: - _
CDR Cesar A. Perez; PhD, Director- · ·_ · .. ·· '-
DRP.2: Division of Establishment Support.
, . Offlcei of-Regulatory Programs .... . . . ..
Office of Product Evaluation and Quality : ':
Center for Devices and Radtologi¢al Meiilth -·
- U.S:Food and Drug Admlnistration,DHHS

..._.; - ,,,. ·.,

,. .. -

·<> ,''_Thifr;i:u-t:ifica_t~Js. 'i{al_ld (rc:i_rn

. ,, ..
--
.~. -
~-(·_.
. , . ·-... ~ ., ,.. . . ' -
-J~ne 06, 2022
. .
to' June 0.5) 2024.
·-· ... ., ... •'

.. _,._ ' ..

. . , .,,.
_,, _.,.·

;. ,..,... ~
.
.
' ..
- .,,. '• . .,-..,
J ' • - --- ~ -.

'L ~- ~ -- '. •
>~J ,:_;,.._>:
 . ·'- ..,._

U,S. Foo.d & Drllg Adm!~litraflon

f 0903·New Hal!Jpsi!lr~. Ave nire
Slim Spring< MD2Q993
www.fda.~ov . ·

. ' . . . . . .- . , .

-: -• Certificate No, .9644;6-2022

·_ . CertifJc~tel~'Fi:ii'elgri
. .., · . Government
. . . .
- Name
. , . 1 of 1
of Manufacturer/Distributor Attachment Page

... - < . , - -:- . . ~-:.-.' =---~ ..: . , . .• . , ..... , - . .

'-: · .. l!iaiue.:'iifCorpQ.rafidieadcf(!:arte i:s
· ~d','o(~r~'s Life_s_clerices L:LC~
-· ·;::; Ori~ EdY.tards Way . ·. >- .

. . :'INirie,.'Gf\> .. -
.....
<. ... , . :~usA92M4
., .. -.. . -•,.
··.. . / -· .
,

y :·· . . _ ·-..,.~~--~- ••. "•••...

·.:- . -~ ;_-Na!h;ct ~,~ft@a,n~{a,ct~~r~-.
_:,·:<-·:. ~--:M,aqiifj(c_ilif$i:• <·-· ·_ _
..'. ·. ·_:: > E,l;l.WARD.S.-L!FES'Cl!:7,NCESAG · .
·-, .. --: :<:PAa'QUETNDUSTRIALITABO' .

. ,,]i~t~:!~,:~···•·
. .,. -~ -~.. ·" . ' ....... ,·· '., '., ,·· ~- : --~·-... -·· , ·.

-•·-:~-:~' ,-~,~:'.~'.~a.1::~~i::~!~°:b~lb~~Qr.
. .°sPWPi~D$J~LF.E$.QJ~Nc~S: (LC- .

_,.. ·. ::/l0N~~~~~~~~t~'_(?<:····
:.· .
•~)I I •--.=_ ,,.,
,USA 92614
: 0
' ....
.-,.
_~.-..•••}~~••••••

:· ,_j igrio:~\lMA~uf;;;i·0~~Rtci(sT_RIBUTOR
:·r >·:_ .. •··- ... . .. Lisr----.
. -~ ~-.:;_~--~~~~-·-·_, ....-->--·--.- - -· . . .. - ·,<_ ...__.
, • ~-;~ ...·• .:...· ·-J
'J~ •• -·-~; • ...,.. • ·;,; '

.. ·::: .· .--,

, , ··.•
......- '

. . . ..-·. - · .. •· ...

·.: ..,-.;: ._-;-:..

. ·_' .,.,.

.<

, -· .. .......
.>~-.; ·---::~-
··_:i<: ··' .:..·_':., .,_:_~···,
.J 1 · : , .-

' .. .....-.. . . .... :,~

"":...>
- ·----... ( x.·. ·"-. - ·· ...
..--<.---:: --~-· .~-:-:--.~ ~-- >~-:--'
:·:-> ··,...
. ... . •
 · U;S.Food&OrugAdmmJstraUoli· ·
10.Q03•New-flarnpshlreAveriue - ·
Sllv.ei Sprin.9,. M.tuo9g3 ·
www.fda;gov

. e·ertrflcate: Nti.Jl~44.:6-202i. -
>- _-::Name ti~f;el9i:Government ..
<&~rtifi~at;:io
oflillanufacturer::: . ··
Name of Product(s) Attachment Page 1 of2

', .u:,,;-ni,.r.::...:,rer .. . .. . .
~ll!'" ··••di"-- . . . . .... :-~- ..

J;r:~,rt··. . .
•- : : ~WARD$;Llfl;SC1E,~C,!',SAG . · _,
· -:-__., . : P'AReciE iNDvstRiAL JTis6-. ·

·-_> · > _._' ~ ~-~;_,--·:~~-:~:·~;--, - ··...:./ .>,.

··-;~~-: ~-~~~;_;tfap,·e~-~f~PrQ.a~el(sf.·. -~ ·.-.> ·-~ ~- ~ · ,.
:a . •' ~-:90•:Set®:1::CJo.s.ed:tojeiita\aJ~y~em.. - ;
:: ; •, :,;93505i 93600,'. '93610;: 93611, 93650, ;
_/~·.:x~~;t~~;~:~i~arf~w-~{~:"~··~'.' ..
•· ·'. siJi'il12;-'5~l~2: .$4JV3?:'~5!,ihoo; ·55iiw;3o, s·a1wvos
. -·, -' ...

_s9iw:sc-;. 5saws6. s~w.sg::sg(awsc, ssuwsc. s9MNVc

,·_..-: _- .. :·-> .. ;·::.. :-:-,~,.~:~.:--• :··:'· > ...: ·. ·.'.:·: ....~ . . ·. .
• , • ""-e"•, - . • - • . . .. -- • ~
.: . _.... .(" ... ( . ··-- ,· ··. . t ' ' .. , :-·· .,_ '. ,· . . . . ' . .. . . .
./ · ·'Tr.i:iWav.e':"': pJsp,osa6.l~P~$-~ure Tr,in~ducei / VAMP® System Combinf!lions.·KJts
:: ,. <iix12N;;rx.{X2,.· FiX200.: P.x2,12;_:'Rx24N;· PX2so. Px212, PX284, PX284R, PX2X2. PX2X3
·: ·:·P~ia~:; ~-fii<i;:P)ax3212;.lPx~61{p.xeooF, Pxsooi-3o, rxeoo1,. i:>xso1, PX604. PXS04l
•~ f~VM_&:::PXAVMP3, .E'XMK\070, _PXM~-1 tm, .PXMK1940; PXMK204'.1, PXMK2043, PXMK2051 .·
PXVMP.120( PXVMP160, 'PXVMP172, •PXVMP184,. PXVMP260, PXVMP272, PXVMP284 .
'> ~- - ,g~efi<2,{,exv,.'.M'p,~f BXYMP2xs\ PXVMP3X31, PXVMPaxa2 · ·
:\ :::·-,PX\l?QS?6/ i:i~p:i'd12-.'.PXVP,fe2eo; PXVP2272, 'P~P2284, PXVP23X3 -
' ; '')6p{iis9A) fooistoA'. ttlQ1li9'lt,1;:too'1737A: T001741 M, T001744M; T001760A .
.: ·,_·<>'..toosoi~Mi :'r 6o~ri.0M/toosti14A, :nooEi11M, T430023M, T4764.11M · ·
, :-. ,,.-:,:~-J/MP306PX, VMP406P-X;VMP-426~x;'vMP448PX :. ;· ' .
. . <" :· .•• ~-··: ,.: "~•-·~ --~~···.~:·:./ .~~ ..~,- _: ·--~ -·~;.:~~~-- -~-~~~-- '. ..~ ·-. ··-· <.-··· ,~_ .. -· .. .
. :. ·oj~~s~b.lefi'r~~sui_i! Trartsdw:~i_A~ssories.
. :;- 6.!l~-169~~:, ?8!<16~12; DTl'!4i PJSS, TRUCLlP, TCLIP05
·..•' . ""' .-.·..._.,·,..·-,,......-:--,-':-....,,.. ---'----c:"----......,...-~--
-_ ': Vi-.MP® (~;!'1ou~/Arte,rl~l:Bl~9iiM~nageh1eni Protection Kits) · . ·
.-· · _' • 4aA.VMP,A8VMP"tos.~4svMP120: 48VMP16o, 4avMP112, 4SVMP184 . .
· ·· :··_ .-4svMP26_0;
' .
48VMP272i ·4aV,MP2a4·, vMPaoei
-: . :;_· .- . . .. ·- . - . - - ..' ...· ' . vMP406, VMP426,
.
VMP448,
. . .
~
VP1;
.
VP2
.
.... · ............-;--......~ ~ - - ~ - - - - - - - - -
•'

·.' , · VAM~ S1,-steiii.Acc,e~s~ri~s· . ·:_ •. . ...

>VMP-400,:-VMP?OO
. ;;~·;~~--~- ....
-48VMP600.-: .. .
·:. ,· '. ... .. . . ~·· . •· . .

.:, '_·>'.. ;·Pre&,l!,!i.r

,11"(9b,1ii9- , ' . . . .. · .. . . · .
:liO#t06~·5op1:1i;:5opfa~. 5,0P}36;"'50P148, 50P180, 50P172, .50P184, 50P200R
·

/ -:,~;~-:::so}'~?~; :~op-2f2,}0f2~/ 50~2~_6, J50P2,i8, 50P260, 50P212, 50P284 . ,

·~ . ·_' . ,. - -~ -- ~ - -_ :C..,- ------- ~- _..;..-'!0 ~-~-.:.~:!....~,-:,...· _
..

- : · : ''F.1<5J~~1>tJNio/(~~TJii:~ll~s;rJ<ii):-_ ~· . . . . -
' ~-·" ;' .' MHD.61: MH865; MH06AZ; M~D6f\25:, MHD6AZA5, MHD6AZR, MHD6AZR5, MHD6R, MHD6R5
0

• . . ~HD,6S;:~HD6,S5, MADS;; MRP~S; M.HP8~, MHD8R, MHD8R5, MHD.8$, MHD8S5 , ' .

~.- . . '·-, .......
~ ./ -,· .
F1ir{a~lo.~~n;ot(l=l6Tr~~16's;nsor Kit) • .' .. . ... . ..
:Mhocir.- ~ 6$', ~H-QQ!fAz'e tv!HP0.6AZ5,. MHDQ6AZA, MHDQ6AZR, MHDQ6AZR5, MHCJ,Q6C502 . ,·-->~:.'->·.
,

·- .·· _-:MHDO~~/·MJ;D,:ctit~i''~HDQ6_~.-!vl_HDQ8, MHDQ85, ,MHDQ8C503, MHDQ8R, MHDQ8R5'

·.-_, · 'iv\Hr:iaas,-MHDQ8.i:f102
·. . . .. .
, ..·
' , --.. , ·;;.:" .......:...:.,.. ·,__,,_-;--~'----------
"' . . '·

,· - : • Acumen ·IC··§~s;fiAcumeii.i6 Sensor Kit) .. .

,· , >: Atasi.::AI.C($&5.; -~cis.$ ~;,i\ios:eA.25, AIQS6AZA;AIQS6AZR, AIQS6AZR5, A1asecsa2 .
.: '.--,~:'/ A1q$~R;)i0,,~6~~-·-~1dss_s:··.·._-:i i,. . .
j~'. ':.> : ''At9~~?,Af(jl.s~;A1~s,soso3,:A19saR, !-'[0S8R5,_AIQS8~,
.. ,~ -~-._· ,· __:.:..:...~-~~-·-~·~-<_--.::..·-..,,...·~"~·,.,.:,'·-·,.,...._·_ _
AIQS8.S1.02
_ _ _ __ ~

~~; .> -:'':-VOlu~~Viii~-Sensor:KiC

":v.·cv·'eR~;: ·- : ' C :; ~ - ..
..,,.-.... . . -, p :· ~ ·--·· . .
• . i, ~ : ·-~ ·...:.· _ .~ ; _ , .- - . : . . . : , . . . - - - . . . . . . . - - ' - - " - - - - - - - - - - - ~

• ,_J" , . __ • • •'• : : . ~ "h •-

> •

·.,..,
·--~✓··.-~?-
;
, ·:

- / ~ . . ....._
 :■·. u~s.•FOOD & DRUG U.5.-Food-& Drug Admlnl&tratlon -
10903 New Humpshlro Avimui
·_ J DM1 NlSTRATIOM Sliver Spilng, Mt"20893
www.f!!a.(lov -
~Pt.I~~ fJ/11 IIADKX.QOICaUlfAl.l lt

. c~rtificat~ N~,9644-f"2022 .
·:. Certificate to.Foreign Government ~ Na.:ne of Product(s) Attachment Page 2 of 2
·: ~\{1000 ci1~i~1-Pi~ffom,liU- · · · · · ·
·. ~Qlear$ig~t;i''lrig_erCuff: : - <-. ':. ' : .
-~SCi ;'Csc.~; C:SC~_CSC2S,CS-C-2M, C.SC2L
,. :~cqi'ij~nJCt F1119,er CUI(
. ·- .A1pcs,-AIQC!v1,.AIQCI:
.. ' . . ' .. . . !cND,OFJ';-i'<ODUCT L I S T - - - - - - - -

'. ~::_ ~ .~ . ··. ··- ~~ - .

. < ......
.•<"" .·.., .,
··: "'·· ~-~ , ~- ·:._ ..
. _,··. ,,. ~ .

{ ,._ .. ~'- ~: ~,:~·"<· . ",( ··.; ··.._,; .

....,
_•,('·•- ~---,_
, _···
... •• ····:.-1'"'
.,,,.·, ..-•"'

'.
. . . . .......
_

. ..: (_ ~ ~-
(. - - ~•·., ..._ ·.
_ _,,. ~- . .

,:~ :-.. A , ,-~ ,

.....~· "•.- ....
.~ . A ..
7 . :.> .,.·