VersaFlex

Basic Information

• Brand Name: VersaFlex
• Primary DI: 07290101365167
• Version / Model: FGS-0538
• Company Name: Given Imaging, Inc.
• Labeler DUNS: 090073722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-29
• Public Version: 3
• Public Version Date: 2022-10-03
• Public Version Status: Update
• Public Device Record Key: 25e2ef7c-9b1e-4869-820e-ddf27ad89411

Device Description

catheter, LPR starter kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFT	Electrode, pH, stomach	Gastroenterology, Urology	876.1400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36965	Gastric pH ambulatory recorder	An electrically-powered device intended for 24-hour recording of the gastric acidity of the stomach through the use of a dedicated sensor. The patient is connected to and wears the device during the recording period and/or while he or she performs normal daily activities. The results will be later analysed using an appropriate device that can read and display the recording.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290101365167	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry;Fragile