Vashe Sterile Sleeve

Basic Information

• Brand Name: Vashe Sterile Sleeve
• Primary DI: 00190769003555
• Version / Model: 00355
• Catalog Number: 00355
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Labeler DUNS: 052758618
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-17
• Public Version: 4
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: ef0eb1a7-b6c2-483f-9966-2edcdfc2ecc5
• Distribution End Date: 2021-12-07

Device Description

The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over an instillation bottle of Vashe Wound Solution to render the outside of the bottle sterile so it may be brought into a sterile field. The spiked cap is aseptically pushed through the septum cap of the bottle, and the sterile splash guard placed over the nozzle tip.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
HMW	Drape, Microscope, Ophthalmic	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10190769003552	GS1	Case	12	Not in Commercial Distribution	2021-12-07
Primary	00190769003555	GS1

Customer Contacts

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