Catachem DiscretPak™ C402-0C

GUDID 00853618007011

Bile Acids (Colormetric) Kit C

CATACHEM, INC.

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• Primary Device ID: 00853618007011
• NIH Device Record Key: f457ef9d-307d-417f-9b35-9cbc259de5cd
• Commercial Distribution Discontinuation: 2018-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Catachem DiscretPak™
• Version Model Number: C402-0C
• Catalog Number: C402-0C
• Company DUNS: 109130625
• Company Name: CATACHEM, INC.
• 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: false
• 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

Customer Support Contacts

• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com
• Phone: 203-262-0330
• Email: info@catacheminc.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853618007011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062503

FDA Product Code

• KWW: Radioimmunoassay, Cholyglycine, Bile Acids

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-30
• Device Publish Date: 2016-11-11