Saline Solution (0.85%) 11-612-001

GUDID B08816120

Saline Solution (0.85%) is a saline solution for viral specimens.

BIO-MED DIAGNOSTICS, INC.

Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Sterile saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD

• Primary Device ID: B08816120
• NIH Device Record Key: 43e96a2f-6d14-426e-b57b-7197a286d9f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saline Solution (0.85%)
• Version Model Number: 1612
• Catalog Number: 11-612-001
• Company DUNS: 605213545
• Company Name: BIO-MED DIAGNOSTICS, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B08816120 [Primary]
HIBCC	B08816121 [Package]; Package: Box [1 Units]; In Commercial Distribution
HIBCC	B08816122 [Package]; Package: Box [50 Units]; In Commercial Distribution

FDA Product Code

• JSG: Culture Media, Non-Selective And Non-Differential

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: 2020-10-07
• Device Publish Date: 2020-09-29

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