221220

GUDID G2982212203

CGA 280 Regulator, 70:30 Heliox, 50 psig, Barbed Outlet, Brown Body

Control Devices, LLC

Non-fixed medical gas cylinder regulator

• Primary Device ID: G2982212203
• NIH Device Record Key: 51466961-da96-4c52-a0bc-8cf87869fff6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2212-20
• Catalog Number: 221220
• Company DUNS: 119290896
• Company Name: Control Devices, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G2982212200 [Primary]
HIBCC	G2982212203 [Package]; Contains: G2982212200; Package: Box [50 Units]; In Commercial Distribution

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: 2024-08-16
• Device Publish Date: 2024-08-08

Devices Manufactured by Control Devices, LLC

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• 00810051631258 - Control Devices: 2025-06-10 CGA 280 Regulator, 80:20 Heliox, 50 psig, Barbed Outlet, Brown Body, DISS 1180 Auxiliary Port
• 00810051631333 - Control Devices: 2025-06-10 CGA 540 Oxygen Regulator, 50 psig, DISS 1240 Outlet
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