EcoMount

GUDID 00847627014405

BIOCARE MEDICAL LLC

Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD Microscopy mounting medium IVD

• Primary Device ID: 00847627014405
• NIH Device Record Key: fba729e9-5b1b-4ead-8fc3-e29d11f12e4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoMount
• Version Model Number: EM897L
• 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: false
• 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 Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627014405 [Primary]

FDA Product Code

• LEB: Mounting Media

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: 2022-10-03
• Device Publish Date: 2022-09-23

Devices Manufactured by BIOCARE MEDICAL LLC

• 00847627035202 - INSM1 [BLR272L]: 2024-04-09
• 00847627035158 - INSM1 [BLR272L]: 2024-03-20
• 00847627035165 - INSM1 [BLR272L]: 2024-03-20
• 00847627035172 - INSM1 [BLR272L]: 2024-03-20
• 00847627035189 - INSM1 [BLR272L]: 2024-03-20
• 00847627035196 - INSM1 [BLR272L]: 2024-03-20
• 00847627035448 - PTEN (Tumor Suppressor): 2024-02-20
• 00847627035462 - MCM2 + TOP2A: 2024-02-16