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ProFusion Therapeutic Infusion Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref G47575Model PTIN-21-7.5
Identity
- Trade Name
- ProFusion Therapeutic Infusion Needle EUDAMEDFDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- ProFusion Therapeutic Infusion Needle EUDAMEDThe ProFusion Needle is a stainless-steel needle with a trocar tip and distal sideports for infusion. The device also consists of a proximal plastic hub for Luer lock connections. FDA UDI
- Model / Reference
- PTIN-21-7.5 EUDAMEDFDA UDIG47575 EUDAMED
- Description
- The ProFusion Needle is a stainless-steel needle with a trocar tip and distal sideports for infusion. The device also consists of a proximal plastic hub for Luer lock connections. FDA UDI
Identifiers
- Catalog Number
- G47575 FDA UDI
- Primary DI / UDI-DI
- 00827002475755 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002475755 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
- GMDN Term
- Subcutaneous infusion/injection port needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Northern 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — 21 Gauge FDA UDILength — 7.5 Centimeter FDA UDI
ProFusion Therapeutic Infusion Needle by Cook BioDevice — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00827002475755 | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cook BioDevice
- EUDAMED SRN
- US-MF-000002783
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (2)
- EUDAMED 1d91d765-d7fe-4168-9b37-a2db3736bf06 61 fields · synced Jul 24, 2026
- FDA UDI 56e7e088-0ca3-445e-ac5e-50ad6974bba7 36 fields · synced May 30, 2026