cobas b 123 Fluid Pack COOX 700 05170052001

GUDID 04015630037650

Roche Diagnostics GmbH

Multiple blood gas analyte IVD, reagent

• Primary Device ID: 04015630037650
• NIH Device Record Key: ff4496f5-5336-4510-b332-60e90cbfe549
• Commercial Distribution Discontinuation: 2024-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: cobas b 123 Fluid Pack COOX 700
• Version Model Number: 5170052001
• Catalog Number: 05170052001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630037650 [Primary]

FDA Product Code

• CHL: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-09-20

Devices Manufactured by Roche Diagnostics GmbH

• 04015630037025 - cobas b 123 Fluid Pack 400: 2024-08-07
• 04015630037032 - cobas b 123 Fluid Pack 700: 2024-08-07
• 04015630037049 - cobas b 123 Fluid Pack 200: 2024-08-07
• 04015630037636 - cobas b 123 Fluid Pack COOX 200: 2024-08-07
• 04015630037643 - cobas b 123 Fluid Pack COOX 400: 2024-08-07
• 04015630037650 - cobas b 123 Fluid Pack COOX 700: 2024-08-07
• 04015630037650 - cobas b 123 Fluid Pack COOX 700: 2024-08-07
• 07613336170304 - Elecsys PTH: 2024-08-07 E2G 300 count
• 07613336170311 - CalSet PTH: 2024-08-07