PREVI™ Isola Applicator Cartrige

GUDID 03573026219680

PREVI ISOLA APPLICATORS CARTRIDGE

BIOMERIEUX , INC.

Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating loop IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument Inoculating tool IVD, analyser/instrument

• Primary Device ID: 03573026219680
• NIH Device Record Key: 6ddf5fb8-c9db-4b1d-9311-6d714862e8b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVI™ Isola Applicator Cartrige
• Version Model Number: PREVI™ Isola Applicator Cartrige
• Company DUNS: 086785110
• Company Name: BIOMERIEUX , INC.
• Device Count: 120
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026219680 [Package]; Contains: 03573026613112; Package: [8 Units]; In Commercial Distribution
GS1	03573026612863 [Unit of Use]
GS1	03573026613112 [Primary]

FDA Product Code

• LXG: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

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: 2020-07-06
• Device Publish Date: 2020-06-26

Devices Manufactured by BIOMERIEUX , INC.

• 03573026636357 - VITEK® 2 AST-N814: 2023-12-14 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026635978 - VITEK® 2 AST-N809: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636142 - VITEK® 2 AST-N811: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636296 - VITEK® 2 AST-N812: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636319 - VITEK® 2 AST-N813: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636333 - VITEK® 2 AST-XN33: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636128 - VITEK® 2 AST-N810: 2023-11-09 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636067 - VITEK® 2 AST-N804: 2023-10-04 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin