Lehman

Basic Information

• Brand Name: Lehman
• Primary DI: 00827002249745
• Version / Model: G24974
• Catalog Number: SOM-18-L-LEHMAN-NG
• Company Name: COOK INCORPORATED
• Labeler DUNS: 079720472
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 164aedeb-38e3-4dd9-81d1-a2dc55cfc6f8

Device Description

Lehman Manometry Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFX	SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)	Gastroenterology, Urology	876.1725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55842	Biliary manometric catheter	A non-electrical, flexible tube intended to be inserted through a flexible endoscope and into the biliary tree to measure pressures within the ducts, especially to evaluate sphincter of Oddi function. The measuring method employed is typically the infusion of water into the catheter (hydraulic manometry) having pressure-sensing membrane cavities along its length that transmit signals to proximally-connected pressure transducers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002249745	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.