AccessGUDID - DEVICE: Bedside Mobility Monitor (00860008806000)

GUDID

Device Identifier (DI) Information

Brand Name: Bedside Mobility Monitor
Version or Model: Rev A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Atlas Lift Tech, Inc.

Primary DI Number: 00860008806000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 034561315 *Terms of Use

Device Description: An in-room device which captures and displays patient’s movement and body orientation from the Mobility Sensor. It sends turning notifications to care staff.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
62115	Ambulatory monitoring/recording system transceiver/cable	An electronic component of an ambulatory patient monitoring/recording system (e.g., ocular volume ambulatory recording system) designed to connect a patient-worn antenna to an ambulatory monitor/recorder for receiving and transmitting data between an implantable or nonimplantable sensor (used in close proximity to the antenna) and the monitor/recorder; it may also be intended to allow wireless power transfer from the parent device to the sensor via the antenna. It is in the form of an electronic circuitry housing with a cable and is powered by the monitor/recorder (battery-powered). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMI	Monitor, Bed 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: 633a9d6b-f3d6-4463-8acc-ca42f5c5c0d5
Public Version Date: August 22, 2023
Public Version Number: 1
DI Record Publish Date: August 14, 2023