AccessGUDID - DEVICE: Jenx (Daytot) (05056235223184)

GUDID

Device Identifier (DI) Information

Brand Name: Jenx (Daytot)
Version or Model: 207-601
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JENX LIMITED

Primary DI Number: 05056235223184
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 291659639 *Terms of Use

Device Description: Joey Size 1 Fabric

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):	Yes
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?
31166	Assistive crawler/mobility board	A device used to provide a person with a disability with a means of mobility, typically without the attendance of another person. It is a wheeled device upon which the person lies or sits, enabling him/her to move around by pushing on the floor with their arms or legs. This device will enhance the user's ability for self-transportation in a local environment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILT	Adaptor, Recreational

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: 64fc0f4e-3783-4735-962f-56bcddc0a552
Public Version Date: August 18, 2025
Public Version Number: 1
DI Record Publish Date: August 08, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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