FDA UDI
In Commercial Distribution
🇺🇸 United States
ViveCare
DI: 00810113576695
·
Model: RHB3021OZ3
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ViveCare
- Primary DI
- 00810113576695
- Version / Model
- RHB3021OZ3
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-20
- Public Version
- 2
- Public Version Date
- 2025-03-10
- Public Version Status
- Update
- Public Device Record Key
- cbe6723a-4ab6-42f4-8fa9-652df46231b4
Device Description
Silver Anti-Microbial Wound Gel
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63108 | Skin semi-occlusive dressing, antimicrobial | A substance (e.g., gel, cream, ointment) intended to be topically applied to injured/diseased skin to expedite skin healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the wound to the environment by means of a physical barrier; it also includes an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds (e.g., abrasions, lacerations, burns, surgical wounds, ulcers) and/or conditions (e.g., eczema, psoriasis, scars). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810113576692 | GS1 | Case | 60 | In Commercial Distribution | |
| Primary | 00810113576695 | GS1 |