AccessGUDID - DEVICE: seca 404 (04012030021593)

GUDID

Device Identifier (DI) Information

Brand Name: seca 404
Version or Model: 404
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4040000009
Company Name: seca GmbH & Co. KG

Primary DI Number: 04012030021593
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316584937 *Terms of Use

Device Description: The ramp is intended to enable the clinical staff to push a patient's wheelchair, bed or stretcher onto the platform of a compatible electronic platform 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?
30147	Fixed ramp	A fixed sloping surface designed to bridge a limited gap between two levels. It is used to move objects or persons from one level to another level. The device would typically be permanently installed at a hospital, institution or at the home of a person with a disability using, e.g., a wheelchair, allowing them to move from one level to another and/or to gain access to a building entrance.	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: 1c31a212-4324-4895-a6b7-21003a86b347
Public Version Date: May 09, 2024
Public Version Number: 1
DI Record Publish Date: May 01, 2024