RELiZORB

GUDID 20862205000230

Ezyme Packed Cartridge with ENFit

Alcresta Therapeutics, Inc.

Enteral feed fat-digestion cartridge

• Primary Device ID: 20862205000230
• NIH Device Record Key: 792803d6-67e0-4b6b-8f63-6962b9218606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELiZORB
• Version Model Number: 100300/100301
• Company DUNS: 078683247
• Company Name: Alcresta Therapeutics, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com
• Phone: 617 714 9946
• Email: apanda@alcresta.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862205000250 [Primary]
GS1	20862205000230 [Package]; Contains: 00862205000250; Package: carton [10 Units]; In Commercial Distribution
GS1	20862205000254 [Package]; Contains: 00862205000250; Package: carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232784

FDA Product Code

• PLQ: Enzyme Packed Cartridge

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: 2024-05-16
• Device Publish Date: 2024-05-08