SALINE SOLUTION

GUDID 03573026617967

Saline Solution is a diluent used for manual preparation of organism suspensions, prior to identification and antimicrobial susceptibility processing with VITEK® 2 instruments.

BIOMERIEUX SA

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 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: 03573026617967
• NIH Device Record Key: 528c4711-96bb-4fa4-a532-6fbb0b1f53a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SALINE SOLUTION
• Version Model Number: SALINE SOLUTION
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: 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 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026617950 [Primary]
GS1	03573026617967 [Package]; Contains: 03573026617950; Package: [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N50510

FDA Product Code

• LON: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-18
• Device Publish Date: 2022-02-10

On-Brand Devices [SALINE SOLUTION]

• 03573026617967: Saline Solution is a diluent used for manual preparation of organism suspensions, prior to ident
• 03573026617943: Saline Solution is a diluent used for manual preparation of organism suspensions, prior to ident