MediVitop

FDA UDI

Class I (US FDA UDI)

by GCE, s.r.o.

Identity

Trade Name: MediVitop FDA UDI
Generic Name: Non-fixed medical gas cylinder regulator FDA UDI
Device Name: The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets. FDA UDI
Model / Reference: MT25 O2 3/4UNF CGA540 DS S FDA UDI
Description: The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets. FDA UDI

Identifiers

Catalog Number: 0712600US FDA UDI
Primary DI / UDI-DI: 08592346855236 FDA UDI
FDA Product Code: CAN FDA UDI
GMDN Term: Non-fixed medical gas cylinder regulator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Non-fixed medical gas cylinder regulator Fixed medical gas cylinder regulator Fixed-regulator oxygen refillable cylinder

MediVitop by GCE, s.r.o. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Fixed-regulator oxygen refillable cylinder.

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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 I	Pending data

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Manufacturer

Manufacturer: GCE, s.r.o.

Sources (1)

FDA UDI 1e81eb58-cd35-4a03-b6fc-4318a0f78fca 34 fields · synced Jun 8, 2026