221020

GUDID G2982210203

CGA 890 Regulator, 70:30 Heliox, 50 psig, Barbed Outlet, Brown Body

Control Devices, LLC

Non-fixed medical gas cylinder regulator

• Primary Device ID: G2982210203
• NIH Device Record Key: 2917e2f5-d42a-409b-9fdf-852214dd66af
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2210-20
• Catalog Number: 221020
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G2982210200 [Primary]
HIBCC	G2982210203 [Package]; Contains: G2982210200; 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: 2024-08-02
• Device Publish Date: 2024-07-25

Devices Manufactured by Control Devices, LLC

• G2981531871600103 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, Barbed Outlet, 0-2 L/min, no pressure gauge
• G298153187160053 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, Barbed Outlet, 0-8 L/min, no pressure gauge
• G298153187270023 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, Barbed Outlet, 0-4 L/min
• G298153187270043 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, Barbed Outlet, 0-8 L/min
• G298153187270053 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, Barbed Outlet, 0-15 L/min
• G298153187270083 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, Barbed Outlet, 0-4 L/min
• G298153187280013 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, DISS 1240 / Xmas Tree Outlet, 0-2 L/min
• G298153187280023 - NA: 2024-08-16 CGA 540 Oxygen Regulator, 50 psig, DISS 1240 / Xmas Tree Outlet, 0-4 L/min