NA

Basic Information

• Brand Name: NA
• Primary DI: 00858778006362
• Version / Model: S2UVC-536
• Company Name: FOOTPRINT MEDICAL, INC.
• Labeler DUNS: 791238046
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f5444221-aaff-497b-82d6-d1ea68401b68

Device Description

5.0Fr Dual Lumen Silicone Umbilical Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOS	Catheter, Umbilical Artery	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10759	Umbilical catheter	A very thin flexible tube designed for umbilical blood vessel access in neonates, typically for the infusion of fluids. It is used mainly in arterial catheterization procedures, but venous catheterization is also possible. It will typically have a double or triple lumen to enable additional concurrent functions such as vital sign monitoring and blood sampling (e.g., for blood gas analysis). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10858778006369	GS1	Carton	5	In Commercial Distribution
Primary	00858778006362	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091213	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	5.0	French