AccessGUDID - DEVICE: Jenx (05056235205982)

GUDID

Device Identifier (DI) Information

Brand Name: Jenx
Version or Model: LY01 010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JENX LIMITED

Primary DI Number: 05056235205982
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 291659639 *Terms of Use

Device Description: Ly-On Activity Frame Size 2

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?
13964	Physical therapy table, non-powered	A dedicated device specifically designed for use in physical therapies. It is a non-powered device that has manually-adjustable table top functions for height and position, including vertical tilting from supine to upright. It will typically incorporate foot supports, straps and exercisers (e.g., pulleys or rotators, arm slings, and leg exercisers). This device is designed for treatment of diseases using therapeutic exercises and massage, e.g., to enhance blood circulation to the lower limbs in patients with neurological disorders (e.g., spinal cord injury) and also to aid in muscle training and sense of balance.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INW	Table, Mechanical

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: c9ad37ef-5160-472f-ad9c-7a1a0212c2be
Public Version Date: October 09, 2023
Public Version Number: 1
DI Record Publish Date: September 29, 2023

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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