FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoject
DI: 20192253036975
·
Model: 8881204005
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
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Basic Information
- Brand Name
- Monoject
- Primary DI
- 20192253036975
- Version / Model
- 8881204005
- Catalog Number
- 8881204005
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2026-02-10
- Public Version
- 1
- Public Version Date
- 2026-02-18
- Public Version Status
- New
- Public Device Record Key
- 91731c9a-1c68-4b6a-88a0-f15ef2a27c0f
Device Description
Medication Transfer Needle 20 G x 1" (0.9 x 25 mm)
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16266 | Medication transfer needle, filtering | A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253036976 | GS1 | CASE | 2 | In Commercial Distribution | |
| Primary | 20192253036975 | GS1 | ||||
| Unit of Use | 10192253036978 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1 | Inch | |
| Needle Gauge | 20 | Gauge |