SalivaGene Swab Comfort 1035231100

GUDID 04250306301110

Invitek Molecular GmbH

Oral/respiratory tract specimen container IVD, additive/medium

• Primary Device ID: 04250306301110
• NIH Device Record Key: d512692a-8bd5-4b54-b794-99008a0dab53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SalivaGene Swab Comfort
• Version Model Number: SalivaGene
• Catalog Number: 1035231100
• Company DUNS: 331869789
• Company Name: Invitek Molecular GmbH
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250306301110 [Primary]

FDA Product Code

• NNI: Container, Specimen, Non-Sterile

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: 2024-11-28
• Device Publish Date: 2024-11-20

Devices Manufactured by Invitek Molecular GmbH

• 04250306301110 - SalivaGene Swab Comfort: 2024-11-28
• 04250306301110 - SalivaGene Swab Comfort: 2024-11-28
• 04250306300915 - PSP SalivaGene DNA Kit: 2024-09-10