FDA.reportPublic FDA data

RELiZORB

Primary DI
00862205000212
Brand
RELiZORB
Company
Alcresta Therapeutics, Inc.
Model
200209 / 200211
Device description
Enzyme Packed Cartridge with ENFit.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLQEnzyme Packed Cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLQEnzyme Packed CartridgeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862205000229PackageGS110In Commercial Distribution
00862205000236PackageGS110In Commercial Distribution
00862205000243PackageGS130In Commercial Distribution
00862205000212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862205000229008622050002298622050002290862205000229
00862205000236008622050002368622050002360862205000236
00862205000243008622050002438622050002430862205000243
00862205000212008622050002128622050002120862205000212

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feed fat-digestion cartridgeA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6177149946rwagner@alcresta.com

Regulatory Flags#

DUNS number
078683247
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862205000250RELiZORB100300/1003012024-05-08
20862205000230RELiZORB100300/1003012024-05-08
00862205000205Relizorb1001032016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00862205000250RELiZORBAlcresta Therapeutics, Inc.PLQ2024-05-08
20862205000230RELiZORBAlcresta Therapeutics, Inc.PLQ2024-05-08
00862205000205RelizorbAlcresta Therapeutics, Inc.PLQ2016-09-23