FDA.reportPublic FDA data

Watch-PAT200U

Primary DI
07290109222691
Brand
Watch-PAT200U
Company
ITAMAR MEDICAL LTD
Model
Watch-PAT200U
Catalog number
AS2150501
Device description
Watch-PAT200U Device
Published
2017-08-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K133859000
K153070000
K161579000
K203839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133859000WATCH-PAT200U (WP200U)Itamar Medical , Ltd.2014-05-30MNR
K153070000Watch-PAT200UItamar Medical , Ltd.2016-07-26MNR
K161579000Watch-PAT200UItamar Medical , Ltd.2017-02-24MNR
K203839000WatchPAT200U (WP200U)Itamar Medical , Ltd.2022-03-21MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109222561PackageGS110
07290109222578PackageGS115
07290109222585PackageGS11
07290109222622PackageGS11In Commercial Distribution
07290109222660PackageGS11In Commercial Distribution
07290109222707PackageGS12
07290109222714PackageGS13
07290109222721PackageGS15
07290109222745PackageGS110In Commercial Distribution
07290109222752PackageGS115In Commercial Distribution
07290109222769PackageGS120In Commercial Distribution
07290109222776PackageGS130In Commercial Distribution
07290109222783PackageGS140In Commercial Distribution
07290109222790PackageGS150In Commercial Distribution
07290109222806PackageGS160In Commercial Distribution
07290109222691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109222561072901092225617290109222561
07290109222578072901092225787290109222578
07290109222585072901092225857290109222585
07290109222622072901092226227290109222622
07290109222660072901092226607290109222660
07290109222707072901092227077290109222707
07290109222714072901092227147290109222714
07290109222721072901092227217290109222721
07290109222745072901092227457290109222745
07290109222752072901092227527290109222752
07290109222769072901092227697290109222769
07290109222776072901092227767290109222776
07290109222783072901092227837290109222783
07290109222790072901092227907290109222790
07290109222806072901092228067290109222806
07290109222691072901092226917290109222691

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 Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246177000info@itamar-medical.com
+97246177000infousa@zoll.com
1-888-748-2627itamar-support@zoll.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109223568WatchPAT400WatchPAT400AS21109002025-12-01
07290109222639Watch-PAT200UWatch-PAT200UAS21505002017-08-09
07290109222882Watch-PAT200UWatch-PAT200UAS21505022018-05-23
07290109222646Watch-PAT200UWatch-PAT200UUS21505002017-08-09
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
07290109223575WatchPAT400WatchPAT400AS21109002025-12-01
07290109222455Watch-PAT300Watch-PAT300AS21107012019-06-30
07290109222479Watch-PAT300Watch-PAT300US21107012019-08-20
07290109222547WatchPAT ONE WatchPAT ONE EAC21108502020-05-12
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
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08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
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08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698524Onera STSOnera B.V.MNR2026-05-15
08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
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09342451002785Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
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09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12