AccessGUDID - DEVICE: COE FOAM™ II (D6585512221)

GUDID

Device Identifier (DI) Information

Brand Name: COE FOAM™ II
Version or Model: 551222
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 551222
Company Name: Gc America Inc.

Primary DI Number: D6585512221
Issuing Agency: HIBCC
Commercial Distribution End Date: September 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: COE FOAM™ II Aerosol Can (18 oz.)

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?
63385	Medical device cleaning agent	A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, medical devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: aafd32ec-6eba-4c93-9b1e-16d85cec8b70
Public Version Date: September 15, 2021
Public Version Number: 3
DI Record Publish Date: February 10, 2017