FDA UDI
In Commercial Distribution
🇺🇸 United States
Heating Pad
DI: 06975641820079
·
Model: BM-ZF0114A
·
Ningbo Kangheng Appliance Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Heating Pad
- Primary DI
- 06975641820079
- Version / Model
- BM-ZF0114A
- Company Name
- Ningbo Kangheng Appliance Co., Ltd.
- Labeler DUNS
- 699453331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-26
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 594cee8d-1317-4178-b4b9-9473f022de11
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11989 | External electric-heating core temperature regulation system pad | An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16975641820076 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 06975641820079 | GS1 |