FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio Compression Systems 4 Chamber Cryo Knee Cylinder - Black
DI: 00812311021823
·
Model: GC-3045-KC/B
·
Bio Compression Systems, Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bio Compression Systems 4 Chamber Cryo Knee Cylinder - Black
- Primary DI
- 00812311021823
- Version / Model
- GC-3045-KC/B
- Company Name
- Bio Compression Systems, Inc
- Labeler DUNS
- 101393924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-21
- Public Version
- 3
- Public Version Date
- 2020-01-29
- Public Version Status
- Update
- Public Device Record Key
- ec1567ef-8175-4ee9-8013-9206b65efe45
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
| ILO | Pack, Hot Or Cold, Water Circulating | Physical Medicine | 890.5720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44768 | Multi-chamber venous compression system garment, reusable | An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812311021823 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961425 | 000 |