Integrity Sterilizers

Basic Information

• Brand Name: Integrity Sterilizers
• Primary DI: 10841736100131
• Version / Model: INTEGRITY 270VP
• Catalog Number: INTEGRITY 270VP
• Company Name: SKYTRON LLC
• Labeler DUNS: 078375583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: eacd8c1b-ee8a-4147-8862-83047b8ef901

Device Description

Integrity 270 Vacuum/Gravity Steam Sterilizer, 26.5"W x 37.5"H x 53"D, Power Door Lock, House Steam, Vacuum Pump

Device Characteristics

• Single Use: No
• 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: 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
FLE	Sterilizer, steam	General Hospital	880.6880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38671	Steam sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841736100131	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132439	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: No Condensation