Retrowash

Basic Information

• Brand Name: Retrowash
• Primary DI: 05060485740001
• Version / Model: RW35
• Company Name: INTERMARK MEDICAL INNOVATIONS LIMITED
• Labeler DUNS: 519829832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 1
• Public Version Date: 2023-06-19
• Public Version Status: New
• Public Device Record Key: 63b7944c-6450-4a88-a1d3-654eb32d313b

Device Description

Retrowash On-Table Lavage/Bowel Washout Kit, 35mm version, for intra-operative washout of the colon in emergency obstructions. The 35mm version is for use where there is little or no bowel distension. After washout, the device facilitates on-table colonoscopy if desired. Sterile. Comprised of 1 x 35mm Handpiece Assembly with 1.6m waste tubing; 1.5m Giving Set; 1.0m Extension Set; 4 x Ties; 2 x 10l Cubitainer waste receptacles.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63299	Colonic lavage kit, surgical	A collection of sterile devices intended to be used during open colorectal surgery (bowel resection) to irrigate the colon above (proximal to) the site of a lesion/blockage, prior to surgical anastomosis, when preoperative preparation of the colon has not been possible, normally due to obstruction. The kit includes a nozzle (intended to be secured to the transected end of the colon above the lesion), an inflow tube, a waste tube, and may include a waste collection bag; it is intended to be connected to a gravity feed bag. The nozzle may also allow colonoscope access for intraoperative colonoscopy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25060485740005	GS1		2	In Commercial Distribution
Primary	05060485740001	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	35	Millimeter