AccessGUDID - DEVICE: TravelJohn® Resealable Duo (00671504700187)

GUDID

Device Identifier (DI) Information

Brand Name: TravelJohn® Resealable Duo
Version or Model: TJ1C-C 70018C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70018C
Company Name: Reach Global Industries, Inc.

Primary DI Number: 00671504700187
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002235674 *Terms of Use

Device Description: TravelJohn® Resealable Industrial Urinal Bags, 1-pack

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:	Yes
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?
40955	Hand-held urinal, single-use	A portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNP	Urinal

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: ac13a7c6-086b-425a-b839-503705a78cee
Public Version Date: July 28, 2023
Public Version Number: 1
DI Record Publish Date: July 20, 2023