IDK Extract®

GUDID 04050598010529

Immundiagnostik AG

Faecal specimen container IVD, transport buffer/medium

• Primary Device ID: 04050598010529
• NIH Device Record Key: 0a29c824-cca7-40ec-bfb9-f76313f3d161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDK Extract®
• Version Model Number: K 6999.20.US
• Company DUNS: 321663841
• Company Name: Immundiagnostik AG
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04050598010529 [Primary]

FDA Product Code

• NNK: Container, Specimen Mailer And Storage, 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: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [IDK Extract®]

• 04050598010529: K 6999.20.US
• 04050598010512: K 6999.17.US
• 04050598010468: K 6999.US