ENFLOW IV FLUID WARMER INSULATED STRAP

Warmer, Thermal, Infusion Fluid

VITAL SIGNS, INC., A GE HEALTHCARE COMPANY

The following data is part of a premarket notification filed by Vital Signs, Inc., A Ge Healthcare Company with the FDA for Enflow Iv Fluid Warmer Insulated Strap.

Pre-market Notification Details

• Device ID: K130867
• 510k Number: K130867
• Device Name: ENFLOW IV FLUID WARMER INSULATED STRAP
• Classification: Warmer, Thermal, Infusion Fluid
• Applicant: VITAL SIGNS, INC., A GE HEALTHCARE COMPANY 20 CAMPUS RD Totowa, NJ 07512
• Contact: Stacie Geffner-atiya
• Correspondent: Stacie Geffner-atiya; VITAL SIGNS, INC., A GE HEALTHCARE COMPANY 20 CAMPUS RD Totowa, NJ 07512
• Product Code: LGZ
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-28
• Decision Date: 2013-06-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10190752188624	K130867	000
50190752178289	K130867	000
50190752147100	K130867	000
10190752125803	K130867	000
10190752125780	K130867	000