Rebyota

Basic Information

• Brand Name: Rebyota
• Primary DI: 07640180262657
• Version / Model: 55566-9850-1
• Company Name: FERRING PHARMACEUTICALS INC.
• Labeler DUNS: 103722955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-24
• Public Version: 1
• Public Version Date: 2023-03-06
• Public Version Status: New
• Public Device Record Key: f8c5a870-24ed-4c11-aadd-ddc7c690196b

Device Description

Administration Set for use with Rebyota

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
64507	Rectal medication/infusion catheter	A flexible tube intended to be inserted into the rectum (may be held in position by an inflatable retention balloon) for administration of a medication solution (e.g. opioids, anti-inflammatory, antibiotics) or infusion of hydration fluid; it may be retained short-term for multiple administrations. It may be supplied with additional disposable devices associated with insertion (e.g. syringe) or medication preparation (e.g., grinder). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640180262657	GS1