Bicarbonate Liquid 08057494190

GUDID 07613336121146

Roche Diagnostics GmbH

Carbon dioxide (CO2) IVD, kit, spectrophotometry

• Primary Device ID: 07613336121146
• NIH Device Record Key: 96812c1f-1c2b-43ed-9c44-25b1d994eea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bicarbonate Liquid
• Version Model Number: 08057494190
• Catalog Number: 08057494190
• 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: false
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336121146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031879

FDA Product Code

• KHS: ENZYMATIC, CARBON-DIOXIDE

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: 2020-03-13
• Device Publish Date: 2020-03-05

Devices Manufactured by Roche Diagnostics GmbH

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• 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
• 07613336170304 - Elecsys PTH: 2024-08-07 E2G 300 count
• 07613336170311 - CalSet PTH: 2024-08-07