enspire

Basic Information

• Brand Name: enspire
• Primary DI: 00724995217501
• Version / Model: enspire 300 Series
• Catalog Number: ENHLD300480NVWD
• Company Name: Corporation Steris Canada
• Labeler DUNS: 202659140
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-17
• Public Version: 3
• Public Version Date: 2024-08-26
• Public Version Status: Update
• Public Device Record Key: f34d0bd6-859d-4871-9038-e8c4ea3fada6

Device Description

The enspire 300 Series Automated Endoscope Reprocessor 480V, Non-vented, Wall Drain is designed to effectively test, clean, high level disinfect, rinse and air purge up to two heat-sensitive, immersible, reusable, semi-critical devices including, but not limited to, GI flexible endoscopes such as bronchoscopes, gastroscopes, and duodenoscopes; or up to six non-channeled naso-endoscopes.

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: Yes
• Has Lot/Batch Number: No
• 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
MED	Sterilant, medical devices	General Hospital	880.6885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66649	Endoscope washer-disinfector (chemical)	An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995217501	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230560	000
K232918	000