Sonata® IUUS probe Leak Tester Kit

Basic Information

• Brand Name: Sonata® IUUS probe Leak Tester Kit
• Primary DI: 10817929020449
• Version / Model: ACCY-016
• Catalog Number: ACCY-016
• Company Name: GYNESONICS, INC.
• Labeler DUNS: 618493741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: 7c6469ef-12e7-46ee-8bdd-c0128f544c51

Device Description

Invasive medical device leak tester, mechanical.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38460	Invasive medical device leak tester, mechanical	A hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817929020449	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius