Relizorb
GUDID 00862205000205
Enzyme Packed Cartridge
ALCRESTA PHARMACEUTICALS, INC
Enteral feed fat-digestion cartridge| Primary Device ID | 00862205000205 |
| NIH Device Record Key | c2a80efd-179b-488b-9b65-0e901ee757c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Relizorb |
| Version Model Number | 100103 |
| Company DUNS | 078683247 |
| Company Name | ALCRESTA PHARMACEUTICALS, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@alcresta.com | |
| Phone | 6177149946 |
| rwagner@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 |
| 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 |
| 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 | 00862205000205 [Primary] |
| GS1 | 10862205000202 [Package] Package: Box [30 Units] In Commercial Distribution |
| GS1 | 20862205000209 [Package] Contains: 10862205000202 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 30862205000206 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 40862205000203 [Package] Contains: 30862205000206 Package: Case [24 Units] In Commercial Distribution |
| GS1 | 50862205000200 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 60862205000207 [Package] Contains: 50862205000200 Package: Case [24 Units] In Commercial Distribution |
FDA Product Code
| PLQ | Enzyme Packed Cartridge |
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 | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Relizorb]
| 00862205000212 | Enzyme Packed Cartridge with ENFit. |
| 00862205000205 | Enzyme Packed Cartridge |
Trademark Results [Relizorb]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIZORB 86690981 5087672 Live/Registered |
ALCRESTA THERAPEUTICS, INC. 2015-07-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.