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Collection Set, Male Connector
EUDAMEDFDA UDIClass I (EU MDR)
Ref PS6100Model TF-1001
Identity
- Trade Name
- Collection Set, Male Connector EUDAMEDCollection set FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- Collection Set EUDAMEDTubing used for suction of fluid and tissue. FDA UDI
- Model / Reference
- TF-1001 EUDAMEDPS6100 EUDAMEDFDA UDI
- Description
- Tubing used for suction of fluid and tissue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051223004486 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051223004486 EUDAMED
- FDA Product Code
- GAZ FDA UDI
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Suction system catheter, general-purpose FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Spain 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Collection Set, Male Connector by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051223004486 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 1800faa7-658a-4bb3-b222-97f116b13e70 61 fields · synced Oct 7, 2026
- FDA UDI 89082b5b-26de-4b90-b8d1-ca9e7194223e 35 fields · synced May 30, 2026