Mediplus

FDA UDI

Class II (US FDA UDI)

by Mediplus , Ltd.

Identity

Trade Name: Mediplus FDA UDI
Generic Name: Urological pressure monitoring tubing set FDA UDI
Device Name: Twin Extension set, 150cm long FDA UDI
Model / Reference: 9115 FDA UDI
Description: Twin Extension set, 150cm long FDA UDI

Identifiers

Primary DI / UDI-DI: 05055140703279 FDA UDI
FDA Product Code: FEN FDA UDI
GMDN Term: Urological pressure monitoring tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.1 Millimeter FDA UDI
Length — 150.0 Centimeter FDA UDI
Lumen/Inner Diameter — 1.5 Millimeter FDA UDI

Category: Urological pressure monitoring tubing set

Mediplus by Mediplus , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mediplus , Ltd.

Sources (1)

FDA UDI fae14104-0baf-46b6-b3b4-edf72419931e 35 fields · synced May 30, 2026