Ethanol Gen.2 08057630190

GUDID 07613336121221

Roche Diagnostics GmbH

Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 07613336121221
• NIH Device Record Key: 9ded4765-13e9-4baf-880d-42f43e936e4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethanol Gen.2
• Version Model Number: 08057630190
• Catalog Number: 08057630190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336121221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951595

FDA Product Code

• DIC: ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

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

On-Brand Devices [Ethanol Gen.2]

• 07613336157817: 08445672190
• 07613336121221: 08057630190