MediReg II 0724104US

GUDID 08592346786585

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.

GCE, s.r.o.

Non-fixed medical gas cylinder regulator
Primary Device ID08592346786585
NIH Device Record Key68a8d632-82a9-4925-b381-fda616183fa0
Commercial Distribution Discontinuation2023-02-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMediReg II
Version Model NumberMR15F O2 CGA540_ _ 9/16 G
Catalog Number0724104US
Company DUNS819753190
Company NameGCE, s.r.o.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108592346786585 [Primary]

FDA Product Code

CANRegulator, Pressure, Gas Cylinder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-09
Device Publish Date2023-02-01

Devices Manufactured by GCE, s.r.o.

08592346978812 - MediVital E2025-08-18 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
08592346893382 - Varimed2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
08592346893399 - Varimed+2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
08592346893405 - Varimed2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
08592346893412 - Varimed+2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
08592346893429 - Varimed2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
08592346893436 - Varimed2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
08592346918276 - Varimed2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.