Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Medication transfer needle, non-filtering/non-vented FDA UDI
- Device Name
- Monoject™ Bluntfill Needle, 18G x 1-1/2” (1.27 mm x 3.8 cm) EUDAMEDBluntfill FDA UDI
- Model / Reference
- 11811022 EUDAMEDFDA UDI
- Description
- Bluntfill FDA UDI
Identifiers
- Catalog Number
- 11811022 FDA UDI
- Primary DI / UDI-DI
- 10884521544826 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10884521544826 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Medication transfer needle, non-filtering/non-vented FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDILength — 1.5 Inch FDA UDI
Category: Medication transfer needle, non-filtering/non-vented
Monoject by Cardinalhealth — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medication transfer needle, non-filtering/non-vented.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Medic Anti-stick Needle/Connector — NxStage Medical, Inc. · Class II
- Monoject — Cardinal Health 200, LLC · Class II
- Ceros — RHINO MEDICAL SUPPLY INC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class I
- BD Blunt Fill NRFit — BECTON DICKINSON AND COMPANY · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (2)
- FDA UDI 2762f288-e606-4cb2-8de5-ab9dd272972f 36 fields · synced Jul 26, 2026
- EUDAMED 0a3403d7-722e-4e79-9ed2-83c86b8a943a 61 fields · synced Jul 26, 2026