AccessGUDID - DEVICE: KENOREX (00810003751218)

GUDID

Device Identifier (DI) Information

Brand Name: KENOREX
Version or Model: 404086
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 404086
Company Name: KENTRON HEALTHCARE, INC.

Primary DI Number: 00810003751218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618825723 *Terms of Use

Device Description: VOMIT AND URINE CLEAR BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" RIGID OPENING AT THE TOP

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
For Single-Use:	Yes
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?
36258	Emesis bag	A disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNY	Basin, Emesis

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: aeee0936-910c-4197-8fe9-f0844e526bba
Public Version Date: December 19, 2018
Public Version Number: 1
DI Record Publish Date: November 18, 2018