FDA UDI
In Commercial Distribution
🇺🇸 United States
CarboJet® CO2 Bone Lavage System
DI: 00818720011806
·
Model: 25-500-0246
·
Kinamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CarboJet® CO2 Bone Lavage System
- Primary DI
- 00818720011806
- Version / Model
- 25-500-0246
- Catalog Number
- 25-500-0246
- Company Name
- Kinamed, Inc.
- Labeler DUNS
- 184896645
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-22
- Public Version
- 3
- Public Version Date
- 2023-07-20
- Public Version Status
- Update
- Public Device Record Key
- 1b4a6a37-24e0-44e4-9ce9-d156ec9ad63c
Device Description
VacuJet® Suction Tube, Long
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQH | Lavage, Jet | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64139 | Bone cleaning gas-jet Y-piece connector | A Y-shaped tube intended to interface a bone cleaning gas-jet assembly and suction pump to allow gas [usually carbon dioxide (CO2)] and alternatively suction to be delivered to the surgical site during gas jet cleaning of bone during an open surgical orthopaedic procedure. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818720011806 | GS1 |