I.V. Catheter

GUDID 16945060530016

The proposed device, l.V, Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.

Jiang Xi Sanxin Medtec Co., Ltd.

Peripheral intravenous cannula
Primary Device ID16945060530016
NIH Device Record Keybbbbb7aa-7ba3-482e-963f-79bdb869bc5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameI.V. Catheter
Version Model NumberY Type-01(18G/30mm)
Company DUNS530079367
Company NameJiang Xi Sanxin Medtec Co., Ltd.
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945060530019 [Primary]
GS116945060530016 [Package]
Contains: 06945060530019
Package: [50 Units]
In Commercial Distribution
GS126945060530013 [Package]
Package: [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 Date2025-03-27
Device Publish Date2025-03-19

On-Brand Devices [I.V. Catheter]

16945060530023The proposed device, l.V, Catheter, is intended to be inserted in to a patient's vascular system
16945060530016The proposed device, l.V, Catheter, is intended to be inserted in to a patient's vascular system

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