GUDID 10858778006352

4.0Fr Dual Lumen Silicone Umbilical Catheter

FOOTPRINT MEDICAL, INC.

Umbilical catheter
Primary Device ID10858778006352
NIH Device Record Keybffe8235-dd72-4db0-9063-60d55efa9754
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2UVC-436
Company DUNS791238046
Company NameFOOTPRINT MEDICAL, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2102262600
Emailinfo@footprintmed.com

Device Dimensions

Catheter Gauge4 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100858778006355 [Primary]
GS110858778006352 [Package]
Contains: 00858778006355
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOSCatheter, Umbilical Artery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

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