AccessGUDID - DEVICE: PHS - XS (04041925006117)

GUDID

Device Identifier (DI) Information

Brand Name: PHS - XS
Version or Model: GBS 01.YY.ZZ
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A008-685
Company Name: medica - Medizintechnik GmbH

Primary DI Number: 04041925006117
Issuing Agency: GS1
Commercial Distribution End Date: May 12, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 328011325 *Terms of Use

Device Description: The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e.g. for gait training, treadmills or ceiling systems. The attachment points are located above the head and stabilization points at hip height.

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?
37480	General-purpose patient lifting system sling/harness	A general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	System, Isokinetic Testing And Evaluation

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: f21a760e-a736-4f01-8c76-5953a490781f
Public Version Date: May 14, 2026
Public Version Number: 2
DI Record Publish Date: November 14, 2024