Brodmerkel

Basic Information

• Brand Name: Brodmerkel
• Primary DI: 00827002222144
• Version / Model: G22214
• Catalog Number: CDSB-10
• Company Name: COOK INCORPORATED
• Labeler DUNS: 079720472
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 81655188-ab86-46aa-9771-30d18a7a016a
• Distribution End Date: 2016-12-05

Device Description

Brodmerkel Colon Decompression Set

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
FEG	TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61910	Colonic decompression tube	A sterile, thin, flexible, hollow cylinder intended to be used to mechanically decompress the colon, typically by connection to an intermittent suction system, to treat conditions including non-toxic megacolon, pseudo-obstruction (Ogilvie syndrome) and/or colonic strictures. It includes a guidewire which is inserted per rectum using a colonoscope (not included) under fluoroscopic assistance. It is made of plastic and rubber materials and may be a straight or pigtail tube with drainage bag connectors/adaptors at the proximal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002222144	GS1

Customer Contacts

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

Storage Conditions

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