AccessGUDID - DEVICE: KLYO (B773KMHBD0)

GUDID

Device Identifier (DI) Information

Brand Name: KLYO
Version or Model: KMHBD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KLYO MEDICAL SYSTEMS INC.

Primary DI Number: B773KMHBD0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058639417 *Terms of Use

Device Description: A mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.

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?
34873	Manual hospital bed	A mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNJ	Bed, Manual

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: 76aac46d-ff3d-4529-95db-443c45faac2b
Public Version Date: March 04, 2024
Public Version Number: 1
DI Record Publish Date: February 23, 2024