Stool preparation system SAS

GUDID 04050598010475

Immundiagnostik AG

Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical Faecal specimen collection kit IVD, clinical

• Primary Device ID: 04050598010475
• NIH Device Record Key: 8b253c3f-4d86-47d7-9367-a0170f264263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stool preparation system SAS
• Version Model Number: K 6998SAS.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: true
• Expiration Date: false
• 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 -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04050598010475 [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 [Stool preparation system SAS]

• 04050598010482: K 6998SAS.20.US
• 04050598010475: K 6998SAS.US