FDA UDI
In Commercial Distribution
🇺🇸 United States
3M™ Bair Hugger™
DI: 50707387790191
·
Model: 57501
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- 3M™ Bair Hugger™
- Primary DI
- 50707387790191
- Version / Model
- 57501
- Catalog Number
- 57501
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-03-16
- Public Version
- 1
- Public Version Date
- 2022-03-24
- Public Version Status
- New
- Public Device Record Key
- 3416a23f-3f0b-485a-b69b-0d55f3b1e8f3
Device Description
3M™ Bair Hugger™ Warming Blanket 57501, Spinal Underbody, 5/Case
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 47682 | Circulating-air whole-body heating/cooling system pad, single-use, sterile | A sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00707387790196 | GS1 | ||||
| Primary | 50707387790191 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060865 | 000 |