AccessGUDID - DEVICE: seca 442 (04012030021081)

GUDID

Device Identifier (DI) Information

Brand Name: seca 442
Version or Model: 442
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4420000009
Company Name: seca GmbH & Co. KG

Primary DI Number: 04012030021081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316584937 *Terms of Use

Device Description: The handrail supports persons who cannot stand independently for a longer period of time while being weighed and it can be mounted to a compatible electronic platform scale. The display holder is intended to fix the display of the scale to the handrail. The display cable is intended to connect the display to a compatible scale.

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?
64582	Patient height/weight-measurement standing frame	A framework with handgrips intended to provide a stable support for a patient while standing for measurement of their height and/or weight. It may be freestanding or attached to a stand-on floor scale and/or base plate. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRW	SCALE, PATIENT

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: 479bcca8-1d66-4612-9577-b78c7a403f44
Public Version Date: May 15, 2024
Public Version Number: 1
DI Record Publish Date: May 07, 2024