FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoject
DI: 10192253068863
·
Model: 1186000444
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Monoject
- Primary DI
- 10192253068863
- Version / Model
- 1186000444
- Catalog Number
- 1186000444
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-29
- Public Version
- 1
- Public Version Date
- 2026-02-06
- Public Version Status
- New
- Public Device Record Key
- 14cfd46a-c762-41bf-b8de-a6ce058bd61b
Device Description
60 mL Syringe Catheter Tip
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) | General Hospital | 880.6960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35390 | Irrigation syringe | A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20192253068860 | GS1 | BOX | 30 | In Commercial Distribution | |
| Primary | 10192253068863 | GS1 | ||||
| Package | 50192253068861 | GS1 | CASE | 4 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 60 | Milliliter |