FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10197106530290
·
Model: 11-6951I
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10197106530290
- Version / Model
- 11-6951I
- Catalog Number
- 11-6951I
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-12
- Public Version
- 1
- Public Version Date
- 2024-01-22
- Public Version Status
- New
- Public Device Record Key
- a32e9dbf-0e0d-4960-aecf-ebf00609c2b0
Device Description
SHAVE TRAY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJA | Intravenous extension tubing set | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33403 | Pleurocentesis/paracentesis kit | A collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50197106530298 | GS1 | CASE | 40 | In Commercial Distribution | |
| Primary | 10197106530290 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 40 Degrees Celsius