FDA UDI
In Commercial Distribution
🇺🇸 United States
Dr Pats
DI: 00810178881208
·
Model: RHB3054BLU4PAK
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dr Pats
- Primary DI
- 00810178881208
- Version / Model
- RHB3054BLU4PAK
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-05
- Public Version
- 1
- Public Version Date
- 2026-02-13
- Public Version Status
- New
- Public Device Record Key
- 7443011c-1047-4565-9045-a91cb4840a6f
Device Description
Cold Compression Bandage 4"x10.5" 4PK
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61595 | Moist-cold pressure bandage | A non-sterile strip or roll of fabric pre-soaked in an alcohol solution intended to be applied to cool and compress a local area of the body (i.e., not dedicated to a specific anatomy) for various preventive/therapeutic applications such as reducing pain, inflammation, or oedema associated with surgery (i.e., postsurgical) or sports injuries; it is not intended to be used in direct contact with open wounds. It intended for localized cooling through evaporation (moist cold therapy). This is a single-patient reusable device after the alcohol solution is replenished. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810178881208 | GS1 |