Clinical Blood Gas Mixture

GUDID 00860009502017

For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.

Roberts Oxygen Company, Inc.

Blood gas analyser IVD, point-of-care

• Primary Device ID: 00860009502017
• NIH Device Record Key: 3e44c195-ce6c-4f2e-9722-b543191abd33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clinical Blood Gas Mixture
• Version Model Number: 1
• Company DUNS: 791818008
• Company Name: Roberts Oxygen Company, Inc.
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009502017 [Primary]

FDA Product Code

• BXK: Gas, Calibration (Specified Concentration)

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: 2022-11-23
• Device Publish Date: 2022-11-15

Devices Manufactured by Roberts Oxygen Company, Inc.

• 00860009502017 - Clinical Blood Gas Mixture: 2022-11-23For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
• 00860009502017 - Clinical Blood Gas Mixture: 2022-11-23 For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
• 00860009502024 - Calibration Gas Mixture: 2022-11-23 Used to calibrate various medical analyzers and other medical equipment.
• 00860009502031 - Artificial Atmosphere Mixture: 2022-11-23 Used to grow and sustain anaerobic, aerobic bacteria, or cultures in a biological incubator.
• 00860009502048 - Laser Gas Mixture: 2022-11-23 Gases utilized as a medium for various medical lasers.
• 00860009502000 - Lung Diffusion Mixture: 2022-11-17 Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.