MR AIR_PI_DS _ _ G

GUDID 08592346893443

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 ID: 08592346893443
• NIH Device Record Key: 628925a5-9362-4f0d-9f3d-7a062156caf4
• Commercial Distribution Discontinuation: 2023-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MR AIR_PI_DS _ _ G
• Version Model Number: 0724109US
• Company DUNS: 819753190
• Company Name: GCE, s.r.o.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592346893443 [Primary]

FDA Product Code

• CAN: Regulator, Pressure, Gas Cylinder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-20
• Device Publish Date: 2023-12-12

Devices Manufactured by GCE, s.r.o.

• 08592346978812 - MediVital E: 2025-08-18 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346893382 - 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.
• 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 - 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.
• 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 - 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.
• 08592346893436 - 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.
• 08592346918276 - 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.