Tube Organiser

EUDAMEDFDA UDI

Class I (EU MDR)

Ref PS5100Model TF-1004

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

Identity

Trade Name: Tube Organiser EUDAMEDFDA UDI
Generic Name: Universal patient tubing holder, sterile FDA UDI
Device Name: Tube Organiser EUDAMED
The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the Tube organiser helps ensure the surgical work area is kept free of the potential of trip and entanglement hazards associated with loose tubing during procedures, and aids prevention of kinking and possible occlusion. FDA UDI
Model / Reference: TF-1004 EUDAMED
PS5100 EUDAMEDFDA UDI
Description: The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the Tube organiser helps ensure the surgical work area is kept free of the potential of trip and entanglement hazards associated with loose tubing during procedures, and aids prevention of kinking and possible occlusion. FDA UDI

Identifiers

Catalog Number: PS5100 FDA UDI
Primary DI / UDI-DI: 05051223004424 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223004424 EUDAMED
FDA Product Code: BYX FDA UDI
EMDN Code: A0380 TUBULAR DEVICES - ACCESSORIES EUDAMED
GMDN Term: Universal patient tubing holder, sterile FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 868.5860 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

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

Tube Organiser by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical…

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-05051223004424	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	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 4cd079aa-e1fb-4a99-a3eb-21f0859a342d 61 fields · synced Oct 8, 2026
FDA UDI 57f7ce63-457c-4ab8-88e6-9901c6ae9dd9 36 fields · synced May 30, 2026