Solventum™ Bair Hugger™ 84003

GUDID 00197998155956

Solventum™ Bair Hugger™ Flex Warming Gown, 84003, Kit, Standard, 30/CS

Solventum US LLC

External circulating-air core temperature regulation system pad, single-use

• Primary Device ID: 00197998155956
• NIH Device Record Key: 3923c000-869e-4e59-a178-795dfed2d831
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Bair Hugger™
• Version Model Number: 84003
• Catalog Number: 84003
• Company DUNS: 119004140
• Company Name: Solventum US LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998155949 [Primary]
GS1	00197998155956 [Package]; Contains: 00197998155949; Package: CASE [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060865

FDA Product Code

• DWJ: System, thermal regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

On-Brand Devices [Solventum™ Bair Hugger™]

• 00197998318184: Solventum™ Bair Hugger™ Warming Gown Kit, 84001, Standard, 30/CS
• 00197998158490: Solventum™ Bair Hugger™ Booties, 90065, Standard, 30/CS
• 00197998158469: Solventum™ Bair Hugger™ Booties, 90091, X-Large, 30/CS
• 00197998156410: Solventum™ Bair Hugger™ Universal Warming Gown with Insulation, 81106, Standard, 20/CS
• 00197998156397: Solventum™ Bair Hugger™ Universal Warming Gown with Insulation, 81107, X-Large, 20/CS
• 00197998156373: Solventum™ Bair Hugger™ Universal Warming Gown with Insulation, 81105, Small, 20/CS
• 00197998156038: Solventum™ Bair Hugger™ Plus Warming Gown, 81102, Small, 20/CS
• 00197998156014: Solventum™ Bair Hugger™ Plus Warming Gown, 84002, Kit, Standard, 30/CS
• 00197998155994: Solventum™ Bair Hugger™ Plus Warming Gown, 81202, X-Large
• 00197998155970: Solventum™ Bair Hugger™ Pediatric Warming Gown, 81501, 20/CS
• 00197998155956: Solventum™ Bair Hugger™ Flex Warming Gown, 84003, Kit, Standard, 30/CS
• 00197998155932: Solventum™ Bair Hugger™ Flex Warming Gown, 81203, X-Large, 20/CS
• 00197998155918: Solventum™ Bair Hugger™ Plus Warming Gown, 81002, Standard, 30/CS
• 00197998155895: Solventum™ Bair Hugger™ Flex Warming Gown, 81003, Standard, 30/CS
• 00197998155871: Solventum™ Bair Hugger™ Flex Warming Gown, 81103, Small, 20/CS
• 00197998155116: Solventum™ Bair Hugger™ Flex Warming Gown, 84203, Kit, X-Large, 20/CS
• 00197998155093: Solventum™ Bair Hugger™ Warming Gown Kit, 84201, X-Large, 20/CS
• 00197998155079: Solventum™ Bair Hugger™ Warming Gown, 81101, Small, 20/CS
• 00197998155055: Solventum™ Bair Hugger™ Warming Gown, 81201, X-Large, 20/CS
• 00197998155031: Solventum™ Bair Hugger™ Plus Warming Gown, 84202, Kit, X-Large, 20/CS
• 00197998155017: Solventum™ Bair Hugger™ Flex Warming Gown with Booties, 83003, Standard, 30/CS
• 00197998154997: Solventum™ Bair Hugger™ Warming Gown with Booties, 83001, Standard, 30/CS
• 00197998154973: Solventum™ Bair Hugger™ Warming Gown, 81001, Standard, 30/CS