Model: FF-344
DI: 06951013002984
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a9190148-ed99-4c8b-b8a1-508d942f555a
Distribution Status:
In Commercial Distribution
DUNS Number:
548017546
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
16951013002981
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06951013002984
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06951013002984
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Carton
Item #3 - Device ID:
26951013002988
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
4
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
16951013002981
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 47681
Name: External circulating-air core temperature regulation system pad, single-use
Definition:
An underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device.
FDA Product Codes
DWJ
System, Thermal Regulating