AccessGUDID - DEVICE: seca 438 (04012030021647)

GUDID

Device Identifier (DI) Information

Brand Name: seca 438
Version or Model: 438
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4380000009
Company Name: seca GmbH & Co. KG

Primary DI Number: 04012030021647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316584937 *Terms of Use

Device Description: The connection kit is intended to couple two individual, compatible electronic platform scales together to form a scale for bigger objects. The kit contains a mechanical connection as well as an electric connection and allows to use one display for two compatible electronic platform scales.

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?
15053	Wheelchair-accessible platform scale	An electronic device designed to measure the weight of a wheelchair occupant who is unable to vacate their wheelchair; it may in addition be intended to function as a patient stand-on scale. It is designed as a floor-standing or floor-integrated platform whereby the known weight of the wheelchair is subtracted from the total measured weight to provide the weight of the wheelchair occupant; it is not designed to weigh a bed/stretcher.	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: 47911474-d799-4222-9ecc-b178e01c8011
Public Version Date: May 09, 2024
Public Version Number: 1
DI Record Publish Date: May 01, 2024