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16-Gauge 1.0" Purple TwoFer Huber-Tipped Vented Needle
EUDAMEDFDA UDIClass I (EU MDR)
Ref 16004Model Transfer Needle
Identity
- Trade Name
- 16-Gauge 1.0" Purple TwoFer Huber-Tipped Vented Needle EUDAMEDTwoFer Needle FDA UDI
- Generic Name
- Medication transfer needle, non-filtering/non-vented FDA UDI
- Device Name
- TwoFer Huber-Tipped Vented Needle EUDAMEDTwoFer Huber-Tipped Needle FDA UDI
- Model / Reference
- Transfer Needle EUDAMED16004 EUDAMEDFDA UDI
- Description
- TwoFer Huber-Tipped Needle FDA UDI
Identifiers
- Catalog Number
- 16004 FDA UDI
- Primary DI / UDI-DI
- 00853832007071 EUDAMEDFDA UDI
- Basic UDI-DI
- 00853832007100588 EUDAMED
- 510(k) Number
- K832347 FDA UDI
- FDA Product Code
- LHI FDA UDI
- EMDN Code
- A0199 NEEDLES - OTHER EUDAMED
- GMDN Term
- Medication transfer needle, non-filtering/non-vented FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Belgium 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
No
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
No
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 — 16 Gauge FDA UDI
16-Gauge 1.0" Purple TwoFer Huber-Tipped Vented Needle by MedSafety Solutions — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00853832007100588 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MedSafety Solutions
- EUDAMED SRN
- US-MF-000008537
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5ee84e79-f7a8-4480-bf81-5c9281b9ea67 61 fields · synced Jun 17, 2026
- FDA UDI acc45930-e7e6-4375-bfaf-0ac14075154c 37 fields · synced May 30, 2026