AccessGUDID - DEVICE: Celeste+ (00864458000452)

GUDID

Device Identifier (DI) Information

Brand Name: Celeste+
Version or Model: 8.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENSODATA, INC.

Primary DI Number: 00864458000452
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080743964 *Terms of Use

Device Description: Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices

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?
64938	Sleep disorder interpretive software, professional-only	An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNR	Ventilatory Effort Recorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173974	000

Device Exempt from Premarket Submission: No 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: adbd92f4-4c05-4213-a28b-ee673217a12c
Public Version Date: April 15, 2025
Public Version Number: 1
DI Record Publish Date: April 07, 2025