Identity

Trade Name
Collection Set, Male Connector EUDAMED
Collection set FDA UDI
Generic Name
Suction system catheter, general-purpose FDA UDI
Device Name
Collection Set EUDAMED
Tubing used for suction of fluid and tissue. FDA UDI
Model / Reference
TF-1001 EUDAMED
PS6100 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 EUDAMED
Class 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

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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