AccessGUDID - DEVICE: Integrity Sterilizers (10841736100018)

GUDID

Device Identifier (DI) Information

Brand Name: Integrity Sterilizers
Version or Model: INTEGRITY 175
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INTEGRITY 175
Company Name: SKYTRON LLC

Primary DI Number: 10841736100018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: Integrity 175 Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam, 120 Volt

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLE	Sterilizer, steam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122774	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6356da21-32d4-49d3-a5a7-aefeb597d896
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016