FDA UDI
In Commercial Distribution
🇺🇸 United States
BioTab
DI: 00810113576978
·
Model: RHB3023BLKMW
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioTab
- Primary DI
- 00810113576978
- Version / Model
- RHB3023BLKMW
- 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
- 2025-08-15
- Public Version Status
- Update
- Public Device Record Key
- 5c9a48cf-f104-4469-83a5-ddf2306a7c53
Device Description
BT Compression Pump (PCD) 8 Chamber (Medium WIde)
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
- 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 |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16837 | Sequential venous compression system | A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810113576975 | GS1 | Case | 2 | In Commercial Distribution | |
| Primary | 00810113576978 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201982 | 000 |