Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Medication transfer needle, non-filtering/non-vented FDA UDI
- Device Name
- Syringe I.V. Access Blunt Tip FDA UDI
- Model / Reference
- 8881541034 FDA UDI
- Description
- Syringe I.V. Access Blunt Tip FDA UDI
Identifiers
- Catalog Number
- 8881541034 FDA UDI
- Primary DI / UDI-DI
- 20192253037927 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Medication transfer needle, non-filtering/non-vented FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medication transfer needle, non-filtering/non-vented
Monoject by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medication transfer needle, non-filtering/non-vented.
- Medic Anti-stick Needle/Connector — NxStage Medical, Inc. · Class II
- Monoject — Cardinalhealth · Class I
- Ceros — RHINO MEDICAL SUPPLY INC · Class I
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class I
- BD Blunt Fill NRFit — BECTON DICKINSON AND COMPANY · Class I
- Transfer Needle — B. BRAUN MEDICAL INC. · Class II
- Monoject — Cardinalhealth · Class I
- BD Nokor — BECTON DICKINSON AND COMPANY · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 939691d3-b983-4131-a107-ad3b8445289d 34 fields · synced Jun 8, 2026