Dual Chamber Irrigation Pump

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PS3871Model TF1015

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

Identity

Trade Name: Dual Chamber Irrigation Pump EUDAMED
Dual chamber irrigation pump reusable FDA UDI
Generic Name: Irrigation solution pressure infusor FDA UDI
Device Name: Irrigation pump EUDAMED
The re-usable Irrigation pump is a pneumatically operated device that has been designed to apply a pre set controlled pressure to 500ml – 1000ml size bags of saline solution (not supplied), enabling precise delivery of irrigation fluid during laparoscopic procedures utilising one of the Purple Surgical Suction & Irrigation sets (PS3800, PS3801, PS3850ULT or, PS3851ULT). FDA UDI
Model / Reference: TF1015 EUDAMED
PS3871 EUDAMEDFDA UDI
Description: The re-usable Irrigation pump is a pneumatically operated device that has been designed to apply a pre set controlled pressure to 500ml – 1000ml size bags of saline solution (not supplied), enabling precise delivery of irrigation fluid during laparoscopic procedures utilising one of the Purple Surgical Suction & Irrigation sets (PS3800, PS3801, PS3850ULT or, PS3851ULT). FDA UDI

Identifiers

Catalog Number: PS3871 FDA UDI
Primary DI / UDI-DI: 05051223022497 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223022497 EUDAMED
FDA Product Code: KZD FDA UDI
EMDN Code: A03010299 IRRIGATION CONTROLLERS - OTHER EUDAMED
GMDN Term: Irrigation solution pressure infusor FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 880.5420 FDA UDI
Market of Registration: Northern Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Dual Chamber Irrigation Pump 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-05051223022497	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 30079cbc-61a0-40b6-9743-f9b02833a514 61 fields · synced Oct 6, 2026
FDA UDI 4edb97a7-2316-4c95-b182-a0d674b40387 35 fields · synced May 30, 2026