Disposable IV Catheter

GUDID 36941512150911

Shinva Ande Healthcare Apparatus Co., Ltd

Peripheral intravenous cannula
Primary Device ID36941512150911
NIH Device Record Key2f0cfaf1-2531-4df5-9abe-13db1bc934f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable IV Catheter
Version Model NumberIVC07-20
Company DUNS421062164
Company NameShinva Ande Healthcare Apparatus Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116941512150917 [Primary]
GS136941512150911 [Package]
Contains: 16941512150917
Package: box [50 Units]
In Commercial Distribution
GS156941512150915 [Package]
Package: case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-16
Device Publish Date2023-05-08

On-Brand Devices [Disposable IV Catheter]

36941512151086IVC09-26
36941512151079IVC09-24
36941512151062IVC09-22
36941512151055IVC09-20
36941512151048IVC09-18
36941512151031IVC09-16
36941512151024IVC09-14
36941512150942IVC07-26
36941512150935IVC07-24
36941512150928IVC07-22
36941512150911IVC07-20
36941512150904IVC07-18
36941512150898IVC07-16
36941512150881IVC07-14

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