FDA UDI
In Commercial Distribution
🇺🇸 United States
Vive
DI: 00810041986559
·
Model: LVA1006RLP
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Vive
- Primary DI
- 00810041986559
- Version / Model
- LVA1006RLP
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-02
- Public Version
- 1
- Public Version Date
- 2023-01-10
- Public Version Status
- New
- Public Device Record Key
- 9ef4c269-4b47-4d55-91d0-3308c5c001be
Device Description
Wheelchair Bag (Royal Palm)
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 |
|---|---|---|---|---|
| KNO | Accessories, Wheelchair | Physical Medicine | 890.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38495 | Wheelchair article holder | A container (e.g., a wire basket, nylon tote bag, or plastic box) that provides a wheelchair occupant with a receptacle for items (e.g., personal/shopping items, work supplies). The device can be mounted at various locations on the wheelchair depending on the type of wheelchair and configuration of the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810041986556 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 00810041986559 | GS1 |