AccessGUDID - DEVICE: ZONE AIR REPLMT COVER,NYLON, 35.5"X80" (00840828162968)

GUDID

Device Identifier (DI) Information

Brand Name: ZONE AIR REPLMT COVER,NYLON, 35.5"X80"
Version or Model: MCZ-3580N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 14744
Company Name: CURBELL MEDICAL PRODUCTS, INC.

Primary DI Number: 00840828162968
Issuing Agency: GS1
Commercial Distribution End Date: January 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 796452311 *Terms of Use

Device Description: ZONE AIR REPLMT COVER,NYLON, 35.5"X80"

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):	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?
58431	Probiotic bed mattress cover	A device made of soft textile materials shaped to fit over a bed mattress, to protect the mattress and prevent cross-contamination, that is treated/impregnated with probiotic bacteria intended to consume the allergen-containing faecal droppings of house dust mites (HDM) to reduce the risk of patient allergic reactions. The device can be laundered for cleaning. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMW	Cover, Mattress (Medical Purposes)

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: 755439ac-ad03-4490-86f7-6b59a9e3f4dd
Public Version Date: January 09, 2019
Public Version Number: 2
DI Record Publish Date: October 05, 2018