FDA UDI
In Commercial Distribution
🇺🇸 United States
CarboJet® CO2 Bone Lavage System
DI: 00898142001500
·
Model: 25-200-0242
·
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
- 00898142001500
- Version / Model
- 25-200-0242
- Catalog Number
- 25-200-0242
- Company Name
- Kinamed, Inc.
- Labeler DUNS
- 184896645
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-18
- Public Version
- 3
- Public Version Date
- 2023-07-20
- Public Version Status
- Update
- Public Device Record Key
- 0b8e6333-2182-47a2-acaf-0e2287ccc65c
Device Description
Femoral Suction Tube
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 | 00898142001500 | GS1 |