Solventum™ Bair Hugger™

Basic Information

• Brand Name: Solventum™ Bair Hugger™
• Primary DI: 00197998155864
• Version / Model: 81103
• Catalog Number: 81103
• Company Name: Solventum US LLC
• Labeler DUNS: 119004140
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-30
• Public Version: 2
• Public Version Date: 2026-03-16
• Public Version Status: Update
• Public Device Record Key: d13e177b-b8d9-4a19-a331-c6a9db6a463a

Device Description

Solventum™ Bair Hugger™ Flex Warming Gown, 81103, Small, 20/CS

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	System, thermal regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47681	External circulating-air core temperature regulation system pad, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00197998155871	GS1	CASE	20	In Commercial Distribution
Primary	00197998155864	GS1

Customer Contacts

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