CALEX Cap

GUDID EBUH089109870010

Bühlmann Laboratories AG

Faecal specimen container IVD, transport buffer/medium

• Primary Device ID: EBUH089109870010
• NIH Device Record Key: a314c5dc-5c12-4fcb-afd0-c4af8598255b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALEX Cap
• Version Model Number: 08910987001
• Company DUNS: 481261006
• Company Name: Bühlmann Laboratories AG
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBUH089109870010 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-22
• Device Publish Date: 2020-05-27

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• 07613336169926 - fCAL turbo: 2022-06-10
• EBUH089104991900 - fCAL Calibrator Set: 2022-06-10
• EBUH089109870010 - CALEX Cap: 2021-07-22
• EBUH089109870010 - CALEX Cap: 2021-07-22
• EBUHBIPOCTRABS0 - Quantum Blue® Reader: 2021-01-20
• EBUHBKPELACONSET0 - BÜHLMANN fPELA® turbo Control Kit: 2020-06-30