Dewax Solution 1, DS1

GUDID 00847627035486

BIOCARE MEDICAL LLC

Dewaxing solution IVD

• Primary Device ID: 00847627035486
• NIH Device Record Key: 85e75a20-535d-4705-a37b-135ef42f2dcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dewax Solution 1, DS1
• Version Model Number: OPRI6001KT60
• Company DUNS: 806617825
• Company Name: BIOCARE MEDICAL 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: true
• Device Combination Product: false
• Single Use: false
• 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 Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627035486 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2023-10-09
• Device Publish Date: 2023-09-29

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