AccessGUDID - DEVICE: Amsco Evolution (00724995151577)

GUDID

Device Identifier (DI) Information

Brand Name: Amsco Evolution
Version or Model: HC-3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UE42
Company Name: Steris Mexico, S. de R.L. de C.V.

Primary DI Number: 00724995151577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 813116209 *Terms of Use

Device Description: The Amsco Evolution Floorloader - Large. This Amsco Evolution SFPP Steam Sterilizer is configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units are equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, Dart (Bowie-Dick) and vacuum leak test cycles.

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):	No
Over the Counter (OTC):	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 097eb1b9-92a9-4e8c-aee1-d395bce4a220
Public Version Date: October 21, 2020
Public Version Number: 5
DI Record Publish Date: September 14, 2016