AccessGUDID - DEVICE: Cubby Beds (00860007550263)

GUDID

Device Identifier (DI) Information

Brand Name: Cubby Beds
Version or Model: KIT10001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sensory Medical, Inc.

Primary DI Number: 00860007550263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080980318 *Terms of Use

Device Description: Technology Hub Integrated system with camera, light, sensors, & speaker

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?
64513	Bedside monitor remote-viewing software, non-physiological parameter	An application software program intended to be used by a healthcare professional to collect, in real-time, non-physiologic data (e.g., intravenous infusion rates, patient mood, patient position) from a bedside monitor (in a healthcare facility or in the home), to facilitate remote patient monitoring, communication, and event notifications for healthcare providers. It is not intended to collect physiological data.	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: 8e00d9f8-8048-499a-a789-be6b3b3fc12c
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 855-964-2664
Email: raqa@cubbybeds.com

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