AccessGUDID - DEVICE: Watch-PAT 200i (07290109222974)

GUDID

Device Identifier (DI) Information

Brand Name: Watch-PAT 200i
Version or Model: Watch-PAT 200i
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS2150306
Company Name: ITAMAR MEDICAL LTD

Primary DI Number: 07290109222974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531857076 *Terms of Use

Device Description: Watch-PAT200 Device

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polysomnograph	A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

GMDN Preferred Term Name

GMDN Definition

Polysomnograph

A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

FDA Product Code

[?]

Product Code	Product Code Name
MNR	Ventilatory Effort Recorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081037	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
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 68.95 and 103.42 KiloPascal
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 68.95 and 103.42 KiloPascal
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7017bfe2-400f-4461-ab55-297cc8c40898
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 20, 2016