AccessGUDID - DEVICE: ANNE™ One (00860004541707)

GUDID

Device Identifier (DI) Information

Brand Name: ANNE™ One
Version or Model: SA-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sibel Health Inc.

Primary DI Number: 00860004541707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093772547 *Terms of Use

Device Description: ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
12391	Wearable multiple physiological parameter recorder, reusable	An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211305	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: 67565111-0618-4cf4-ab73-36de00979dfa
Public Version Date: November 01, 2023
Public Version Number: 3
DI Record Publish Date: October 20, 2021