FDA UDI
In Commercial Distribution
🇺🇸 United States
Bair Hugger™ Novaplus™
DI: 30608223455341
·
Model: 45534
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Bair Hugger™ Novaplus™
- Primary DI
- 30608223455341
- Version / Model
- 45534
- Catalog Number
- 45534
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 3f36b24d-2af2-4395-8505-448f071d5861
Device Description
3M™ Bair Hugger™ NovaPlus™ Pediatric Underbody Blanket, 10 per case, 45534
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
- 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 |
|---|---|---|---|---|
| 47681 | External circulating-air core temperature regulation system pad, single-use | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30608223455341 | GS1 | ||||
| Unit of Use | 00608223455340 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060865 | 000 |