FDA.reportPublic FDA data

Solventum™ Bair Hugger™

Primary DI
00197998470455
Brand
Solventum™ Bair Hugger™
Company
Solventum US LLC
Model
90107
Catalog number
90107
Device description
Solventum™ Bair Hugger™ Temperature Monitoring YSI 400 Cable, 90108, 3.5mm 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
00197998470462PackageGS15In Commercial Distribution
00197998470455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998470462001979984704621979984704620197998470462
00197998470455001979984704551979984704550197998470455

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
+28006342249regulatoryrequests@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
00197998001246Solventum™ Tegaderm™1877-21001877-21002026-08-23
00197998001277Solventum™ Tegaderm™1879-21001879-21002026-08-23
00197998001369Solventum™ Tegaderm™166416642026-08-23
00197998002861Solventum™ Tegaderm™9132NS9132NS2026-08-23
00197998149016Solventum™ Tegaderm™358435842026-08-23
00197998149047Solventum™ Tegaderm™358235822026-08-23
00197998149078Solventum™ Tegaderm™358735872026-08-23
00197998149382Solventum™ Tegaderm™358635862026-08-23
00197998149412Solventum™ Tegaderm™359335932026-08-23
00197998149443Solventum™ Tegaderm™359035902026-08-23
00197998149474Solventum™ Tegaderm™358835882026-08-23
00197998149504Solventum™ Tegaderm™358935892026-08-23
00197998150340Solventum™ Clinpro™7200M7200M2026-08-23
00197998150371Solventum™ Clinpro™7200W7200W2026-08-23
00197998150401Solventum™ Clinpro™7200FF7200FF2026-08-23
00197998150432Solventum™ Clinpro™7210M7210M2026-08-23
00197998150463Solventum™ Clinpro™7210W7210W2026-08-23
00197998150494Solventum™ Clinpro™7210FF7210FF2026-08-23
00197998150517Solventum™ Clinpro™7220SP7220SP2026-08-23
00197998173523Solventum™ Tegaderm™912491242026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998470431Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
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00842188125362WashersTrimed, INC.NDG2023-01-05
05055662967555Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2022-05-25
00810028392106Arsenal FootTrilliant Surgical, LLCNDG2022-05-02
00810028392113Arsenal FootTrilliant Surgical, LLCNDG2022-05-02
00810028392120TigerTrilliant Surgical, LLCNDG2022-05-02
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