Insufflation Filter/Tubing Set with 15mm/22mm Connector

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS3605Model TF1025

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 15mm/22mm Connector EUDAMED
Insufflation filter / tubing set with 22mm filter FDA UDI
Generic Name: Microbial medical gas filter, sterile, single-use FDA UDI
Device Name: INSUFFLATION FILTERS EUDAMED
The Insufflation filter / tubing set effectively prevents cross contamination between the patient & insufflator. FDA UDI
Model / Reference: TF1025 EUDAMED
PS3605 EUDAMEDFDA UDI
Description: The Insufflation filter / tubing set effectively prevents cross contamination between the patient & insufflator. FDA UDI

Identifiers

Catalog Number: PS3605 FDA UDI
Primary DI / UDI-DI: 05051223004127 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223004127 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: Northern Ireland 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 15mm/22mm 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-05051223004127	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 c2cd7890-b43c-4a96-9183-3fa308db48e8 61 fields · synced Oct 6, 2026
FDA UDI e79462c8-f681-445c-ba37-6d5f0b4a118e 35 fields · synced May 30, 2026