FDA UDI
In Commercial Distribution
🇺🇸 United States
ViveCare
DI: 00810113576992
·
Model: LVA3050BLK
·
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
- 00810113576992
- Version / Model
- LVA3050BLK
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-13
- Public Version
- 1
- Public Version Date
- 2025-05-21
- Public Version Status
- New
- Public Device Record Key
- f99c04e3-336b-46e1-9b3f-0ab870faa017
Device Description
Ostomy Belt (Black)
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
- 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 |
|---|---|---|---|---|
| EXE | Protector, Ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62951 | Ostomy appliance belt | An adjustable and/or elastic, strip-like device intended to secure an ostomy appliance [e.g., bag, irrigation sleeve] (not included) to a patient’s stoma (e.g., in the intestine/colon) during use. The appliance is attached to the device which is worn by the patient; the device does not include an attachment flange, plate, or ring and is not intended to protect the ostomy site or appliance (i.e., does not include a shield). It is typically made of synthetic polymer materials and is intended for use in the home and healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810113576999 | GS1 | Case | 60 | In Commercial Distribution | |
| Primary | 00810113576992 | GS1 |