RELiZORB

GUDID 00862205000212

Enzyme Packed Cartridge with ENFit.

ALCRESTA PHARMACEUTICALS, INC

Enteral feed fat-digestion cartridge

• Primary Device ID: 00862205000212
• NIH Device Record Key: 3b7d0687-e4b7-421d-8904-e93580297dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELiZORB
• Version Model Number: 200209 / 200211
• 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
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: rwagner@alcresta.com
• Phone: 6177149946
• Email: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862205000212 [Primary]
GS1	00862205000229 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00862205000236 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00862205000243 [Package]; Package: Box [30 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