SMARTeZ Pump

GUDID 98859299101050

SMARTez 250-250-60m

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Elastomeric infusion pump system
Primary Device ID98859299101050
NIH Device Record Key2e01a151-4f8b-444b-bb2a-f31fe4005ebf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMARTeZ Pump
Version Model Number481056
Company DUNS662213220
Company NameEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS168859299101059 [Primary]
GS178859299101056 [Unit of Use]
GS198859299101050 [Package]
Contains: 68859299101059
Package: [48 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEBPump, Infusion, Elastomeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-07
Device Publish Date2020-11-27

On-Brand Devices [SMARTeZ Pump]

58859299101151SMARTeZ Pump 250-50-5h
58859299101144SMARTeZ Pump 200-200-1h
58859299101137SMARTeZ Pump 250-125-2h
58859299101120SMARTeZ Pump 250-100-2.5h
58859299101113SMARTeZ Pump 200-100-2h
58859299101106SMARTeZ Pump 400-100-4h
58859299101090SMARTeZ Pump 100-50-2h
58859299101076SMARTeZ Pump 400-200-2h
58859299101069SMARTeZ Pump 250-175-1.5h
58859299101052SMARTeZ Pump 250-250-1h
58859299101045SMARTeZ Pump 100-100-1h
58859299101038SMARTeZ Pump 50-50-1h
58859299101021SMARTeZ Pump 250-500-0.5h
58859299101014SMARTeZ Pump 100-200-0.5h
48859299104056SMARTeZ Pump C270-10-27h
48859299104049SMARTeZ Pump C270-5-54h
48859299104032SMARTeZ Pump C120-4-30h
48859299104025SMARTeZ Pump C270-2-135h
48859299104018SMARTeZ Pump C100-2-50h
48859299101086SMARTeZ Pump 500-250-2h
48859299100195SMARTeZ Pump 270-1-270h
48859299100188SMARTeZ Pump 100-0.5-200h
48859299100171SMARTeZ Pump 300-2-150h
48859299100164SMARTeZ Pump 270-2-135h
48859299100157SMARTeZ Pump 65-0.5-130h
48859299100140SMARTeZ Pump 400-4-100h
48859299100133SMARTeZ Pump 270-4-68h
48859299100126SMARTeZ Pump 100-1.5-67h
48859299100119SMARTeZ Pump 400-5-80h
48859299100102SMARTeZ Pump 120-2-60h
48859299100096SMARTeZ Pump 270-5-54h
48859299100089SMARTeZ Pump 100-2-50h
48859299100072SMARTeZ Pump 400-10-40h
48859299100065SMARTeZ Pump 120-4-30h
48859299100058SMARTeZ Pump 60-2-30h
48859299100041SMARTeZ Pump 270-10-27h
48859299100034SMARTeZ Pump 125-5-25h
48859299100027SMARTeZ Pump 80-5-16h
48859299100010SMARTeZ Pump 60-5-12h
98859299101036SMARTez 50-50-60m
98859299101012SMARTez 100-200-30m
98859299101043SMARTez 100-100-60m
98859299101128SMARTez 250-100-150m
98859299101067SMARTez 250-175-90m
98859299101050SMARTez 250-250-60m
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