Rebyota

GUDID 07640180262657

Administration Set for use with Rebyota

FERRING PHARMACEUTICALS INC.

Rectal medication/infusion catheter

• Primary Device ID: 07640180262657
• NIH Device Record Key: f8c5a870-24ed-4c11-aadd-ddc7c690196b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebyota
• Version Model Number: 55566-9850-1
• Company DUNS: 103722955
• Company Name: FERRING PHARMACEUTICALS 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640180262657 [Primary]

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: 2023-03-06
• Device Publish Date: 2023-02-24

Devices Manufactured by FERRING PHARMACEUTICALS INC.

• 07640180262657 - Rebyota: 2023-03-06Administration Set for use with Rebyota
• 07640180262657 - Rebyota: 2023-03-06 Administration Set for use with Rebyota
• 07640180261018 - ZOMA-Jet: 2021-08-19 Needle-free delivery device for use with ZOMACTON (somatropin) for Injection 10mg vial, 7 Head A's, Carry Case and User Manual.
• 07640180261001 - ZOMA-Jet: 2019-07-22 Needle-fre4e delivery device for use with ZOMACTON (somatropin) for Injection 5mg vial, 5 Head A's, Carry Case and User Manual.
• 07640128544210 - Euflexxa: 2018-07-06 1% sodium hyaluronate