FDA.reportPublic FDA data

Solventum™ Bair Hugger™

Primary DI
00197998156366
Brand
Solventum™ Bair Hugger™
Company
Solventum US LLC
Model
81105
Catalog number
81105
Device description
Solventum™ Bair Hugger™ Universal Warming Gown with Insulation, 81105,Small, 20/CS
Published
2026-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, thermal regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998156373PackageGS120In Commercial Distribution
00197998156366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998156373001979981563731979981563730197998156373
00197998156366001979981563661979981563660197998156366

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-air core temperature regulation system pad, single-useAn 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998040627Solventum™ Paradigm™5314S5314S2026-10-24
00197998040733Solventum™ Paradigm™5514S5514S2026-10-24
00197998041525Solventum™ Micropore™1533-01533-02026-10-23
00197998041556Solventum™ Micropore™1533-11533-12026-10-23
00197998042782Solventum™ Micropore™1530-01530-02026-10-23
00197998054129Solventum™ Micropore™1530-11530-12026-10-23
00197998054150Solventum™ Micropore™1530-21530-22026-10-23
00197998054181Solventum™ Micropore™1533-21533-22026-10-23
00197998054211Solventum™ Micropore™1530S-11530S-12026-10-23
00197998054242Solventum™ Micropore™1530-31530-32026-10-23
00197998040481Solventum™ Paradigm™531153112026-10-17
00197998040511Solventum™ Paradigm™531553152026-10-17
00197998040542Solventum™ Paradigm™5313J5313J2026-10-17
00197998040573Solventum™ Paradigm™531253122026-10-17
00197998040603Solventum™ Paradigm™531353132026-10-17
00197998040658Solventum™ Paradigm™551155112026-10-17
00197998040689Solventum™ Paradigm™551355132026-10-17
00197998040719Solventum™ Paradigm™5513J5513J2026-10-17
00197998040764Solventum™ Paradigm™551555152026-10-17
00197998189616Solventum™ Tegaderm™90212902122026-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0078755104171240675 Hot Pink Pad XL - with Arm ProtectorsXODUS MEDICAL, INC.DWJ2026-10-19
06951013004124KoZee Warming BlanketJiangmen Dacheng Medical Equipment Co., Ltd.DWJ2026-10-15
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
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06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30