FDA.reportPublic FDA data

WatchPAT ONE

Primary DI
07290109222547
Brand
WatchPAT ONE
Company
ITAMAR MEDICAL LTD
Model
WatchPAT ONE E
Catalog number
AC2110850
Device description
WatchPAT ONE E
Published
2020-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183559000
K223675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183559000WatchPAT ONEItamar Medical , Ltd.2019-06-05MNR
K223675000WatchPAT ONE (WP1)Itamar Medical , Ltd.2023-01-06MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109222967PackageGS112In Commercial Distribution
07290109222547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109222967072901092229677290109222967
07290109222547072901092225477290109222547

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure68.95 KiloPascal103.42 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure68.95 KiloPascal103.42 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-888-748-2627itamar-support@zoll.com

Regulatory Flags#

DUNS number
531857076
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109222639Watch-PAT200UWatch-PAT200UAS21505002017-08-09
07290109222882Watch-PAT200UWatch-PAT200UAS21505022018-05-23
07290109222646Watch-PAT200UWatch-PAT200UUS21505002017-08-09
07290109222691Watch-PAT200UWatch-PAT200UAS21505012017-08-09
07290109222738Watch-PAT200UWatch-PAT200UUS21505012017-08-09
07290109222820Itamar Snoring + BP for Watch-PAT 200S-3 and Watch-PAT200UItamar Snoring + BP for Watch-PAT 200S-3 and WatchAC20004002016-09-06
07290109222899Watch-PAT200UWatch-PAT200UUS21505022018-05-23
07290109223193Central Plus Sensor Central Plus Sensor AC30001152023-03-13
07290109223568WatchPAT400WatchPAT400AS21109002025-12-01
07290109223575WatchPAT400WatchPAT400AS21109002025-12-01
07290109222455Watch-PAT300Watch-PAT300AS21107012019-06-30
07290109222479Watch-PAT300Watch-PAT300US21107012019-08-20
07290109223216WatchPAT ONEWatchPAT ONE-M (Canada)AC21118612023-03-13
07290109225371Endo PAT 2000Endo PAT 2000AS16500302017-12-31
07290109225395Endo PAT 2000Endo PAT 2000US16500302017-12-31
07290109225227Accessories, EndoPATxAccessories, EndoPATxAC00016502023-04-27
07290109225425EndoPATxEndoPATxAS16500072023-04-27
07290109223230WatchPAT ONE WatchPAT ONE E (Canada)AC21118512023-03-13
07290109223254WatchPAT ONE WatchPAT ONE (Canada)AC21118012023-03-13
0729010922302512 WatchPAT ONE-M Probes12 WatchPAT ONE-M ProbesAC21013602021-03-18

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