FDA UDI
In Commercial Distribution
🇺🇸 United States
Vive Health
DI: 00818323027129
·
Model: SUP1048M
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Vive Health
- Primary DI
- 00818323027129
- Version / Model
- SUP1048M
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-12
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- f925de88-ab1b-460b-9ead-2c7adab4ae07
Device Description
Posture Corrector Medium
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 |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13810 | Clavicle orthosis | A prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It is formed as a figure-of-eight harness that descends from the shoulders, passes under each arm and crosses over the back. It has broad, padded straps and may have extra padding inserted at the back. This device may also be used to improve the patient's posture. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818323027126 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 00818323027129 | GS1 |