FDA UDI
In Commercial Distribution
🇺🇸 United States
Bed Buddy
DI: 00749836052011
·
Model: TPF5201LP
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Bed Buddy
- Primary DI
- 00749836052011
- Version / Model
- TPF5201LP
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-02
- Public Version
- 2
- Public Version Date
- 2023-08-22
- Public Version Status
- Update
- Public Device Record Key
- 6c8c9620-0042-41b9-90bc-047554f9461b
Device Description
6" x 12" Hot N' Cold Wrap
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | 890.5700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15026 | Moist-cold pack | A non-sterile device intended to be temporarily applied to a particular area of the body surface to provide moist cold. It typically consists of a disposable pad/pack/towel that includes an overlapping of several layers of fabric (e.g., gauze, cotton) and is intended to apply moist cold to the tissues after immersion in cold water and freed from excess moisture; it is not a compression bandage. It is typically used for temporary vasoconstriction of superficial blood vessels to help control bleeding, to inhibit inflammation and microbial activity in the early stages of infection, and to prevent/control oedema after strains or contusions. This is a single-use device. | No | Active |
| 34971 | Moist-heat pack | A device intended to be applied with pressure to the body surface to provide moist heat therapy to reduce muscle spasms and cramps and/or joint and muscle stiffness and pain. It usually consists of a soft pad or a small pouch made of cotton, gauze, or linen available in a variety of thickness; it may also contain gel or absorbent materials. The device can be warmed in hot water or in a microwave oven. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60749836052013 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00749836052011 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]