Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Medication transfer needle, filtering FDA UDI
- Device Name
- Monoject Medication Transfer Needle, 20 G x 1" (0.902 mm x 2.5 cm) EUDAMEDMedication Transfer Needle FDA UDI
- Model / Reference
- 8881204005 EUDAMEDFDA UDI
- Description
- Medication Transfer Needle FDA UDI
Identifiers
- Catalog Number
- 8881204005 FDA UDI
- Primary DI / UDI-DI
- 10884521014855 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10884521014855 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A0199 NEEDLES - OTHER EUDAMED
- GMDN Term
- Medication transfer needle, filtering 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
No
FDA UDI
Over-the-Counter
Yes
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
- Length — 1 Inch FDA UDI
Category: Medication transfer needle, filtering
Monoject by Cardinalhealth — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Medication transfer needle, filtering.
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- BD Integra 18G 1 1/2IN Blunt Filter Needle — BECTON DICKINSON AND COMPANY · Class II
- Filter Needle — B. BRAUN MEDICAL INC. · Class I
- B.BRAUN — B. BRAUN MEDICAL INC. · 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 4facf85a-f002-4ca3-bbb0-316edde76e7a 37 fields · synced Jul 14, 2026
- EUDAMED 01306339-1eba-445a-888f-879a1324f7cd 61 fields · synced Jul 14, 2026