RELiZORB

Basic Information

• Brand Name: RELiZORB
• Primary DI: 00862205000250
• Version / Model: 100300/100301
• Company Name: Alcresta Therapeutics, Inc.
• Labeler DUNS: 078683247
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-08
• Public Version: 1
• Public Version Date: 2024-05-16
• Public Version Status: New
• Public Device Record Key: 792803d6-67e0-4b6b-8f63-6962b9218606

Device Description

Ezyme Packed Cartridge with ENFit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PLQ	Enzyme Packed Cartridge	Gastroenterology, Urology	876.5985	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62270	Enteral feed fat-digestion cartridge	A non-sterile, noninvasive device intended to be connected to an enteral feeding tube to digest (i.e., hydrolyse) the fat content in an enteral feeding solution as it passes through the device, typically used for patients unable to produce pancreatic fat digestive enzymes. It is a small plastic housing with connectors that contains a porous filter and the enzyme lipase. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20862205000230	GS1	carton	10	In Commercial Distribution
Primary	00862205000250	GS1
Package	20862205000254	GS1	carton	30	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K232784	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius