FDA.reportPublic FDA data

Solventum™ Bair Hugger™

Primary DI
00197998470431
Brand
Solventum™ Bair Hugger™
Company
Solventum US LLC
Model
90108
Catalog number
90108
Device description
Solventum™ Bair Hugger™ Temperature Monitoring YSI 400 Cable, 90107,6.35 mm Compatible, 5/CS
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDGWASHER, BOLT, NUT, NON-SPINAL, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDGWasher, Bolt, Nut, Non-Spinal, MetallicOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998470448PackageGS15In Commercial Distribution
00197998470431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998470448001979984704481979984704480197998470448
00197998470431001979984704311979984704310197998470431

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)634-2249regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
1
DM exempt
true
Lot or batch
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
00197998470455Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
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05055662967555Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2022-05-25
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08800089420391INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
08800089420407INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
05055662964844Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2021-06-25
00885556784006EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784013EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784020EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784037EVOSSmith & Nephew, Inc.NDG2021-05-11
20885556746022SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746028SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746035SMART TSFSmith & Nephew, Inc.NDG2020-11-03
08806390891912Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891929Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891936Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390858014VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390858021VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865821Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865838Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390883641Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-02-18
08806390850742ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08806390862288ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815508ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815515ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
00812926029573TigerTrilliant Surgical, LLCNDG2019-08-15