LEAK TEST AIR TUBE

Basic Information

• Brand Name: LEAK TEST AIR TUBE
• Primary DI: 04953170404160
• Version / Model: MAJ-2127
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-18
• Public Version: 2
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: 6a31913a-edd1-4b51-8a79-d555269ad2d1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64509	Endoscope leak tester tubing	A length of flexible tube with connectors intended to deliver a medium (typically air) from a leak tester to the interior of an endoscope during a leak test; it may in addition be intended for other endoscope pre- or post-procedural processing (e.g., allow connection of a fluid seal). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170404160	GS1

Customer Contacts

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