FDA UDI
In Commercial Distribution
🇺🇸 United States
3M™ Bair Hugger™
DI: 00707387803445
·
Model: 89500
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 3M™ Bair Hugger™
- Primary DI
- 00707387803445
- Version / Model
- 89500
- Catalog Number
- 89500
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-12
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- a3069d4b-f6b9-4c38-a770-ff3fc96aaedd
Device Description
3M™ Bair Hugger™ Patient Adjustable Warming Unit, 89500, 120V-ENG-B, Refurbished, 1 Each
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 47652 | External circulating-air core temperature regulation system control unit, heating/cooling | An electrically-powered device intended to be used as part of an external circulating-air core temperature regulation system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a filter, an air heating and cooling mechanism and air pump. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50707387803440 | GS1 | CASE | 1 | In Commercial Distribution | |
| Primary | 00707387803445 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060865 | 000 |