Insufflation Filter/Tubing Set with Luer Lock connector

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS3600Model TF-1025

by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited

Identity

Trade Name: Insufflation Filter/Tubing Set with Luer Lock connector EUDAMED
Insufflation filter / tubing set with luer lock connector FDA UDI
Generic Name: Microbial medical gas filter, sterile, single-use FDA UDI
Device Name: Insufflation Filter/Tubing Set EUDAMED
The Insufflation filter / tubing set effectively prevents cross contamination between the patient & insufflator. FDA UDI
Model / Reference: TF-1025 EUDAMED
PS3600 EUDAMEDFDA UDI
Description: The Insufflation filter / tubing set effectively prevents cross contamination between the patient & insufflator. FDA UDI

Identifiers

Catalog Number: PS3600 FDA UDI
Primary DI / UDI-DI: 05051223004073 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223004073 EUDAMED
FDA Product Code: NKC FDA UDI
EMDN Code: K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED
GMDN Term: Microbial medical gas filter, sterile, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 884.1730 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Insufflation Filter/Tubing Set with Luer Lock connector by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, 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-05051223004073	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
EUDAMED SRN: GB-MF-000012819
Authorised Representative: Advena Limited MT-AR-000000234

Sources (2)

EUDAMED 9a6d7d97-c26d-412b-beb4-402e83e2cdd1 61 fields · synced Oct 6, 2026
FDA UDI 8debfdb6-4d8a-4f21-a421-a613d4e7552d 35 fields · synced May 30, 2026