FDA.reportPublic FDA data

Watch-PAT300

Primary DI
07290109222462
Brand
Watch-PAT300
Company
ITAMAR MEDICAL LTD
Model
Watch-PAT300
Catalog number
AS2110701
Device description
Watch-PAT300 Device
Published
2019-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K180775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180775000Watch-PAT300Itamar Medical , Ltd.2018-08-17MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109222141PackageGS11In Commercial Distribution
07290109222158PackageGS11In Commercial Distribution
07290109222165PackageGS11In Commercial Distribution
07290109222172PackageGS11In Commercial Distribution
07290109222226PackageGS11In Commercial Distribution
07290109222233PackageGS11In Commercial Distribution
07290109222240PackageGS11In Commercial Distribution
07290109222257PackageGS11In Commercial Distribution
07290109222462PackageGS11In Commercial Distribution
07290109222554PackageGS115In Commercial Distribution
07290109222455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109222141072901092221417290109222141
07290109222158072901092221587290109222158
07290109222165072901092221657290109222165
07290109222172072901092221727290109222172
07290109222226072901092222267290109222226
07290109222233072901092222337290109222233
07290109222240072901092222407290109222240
07290109222257072901092222577290109222257
07290109222462072901092224627290109222462
07290109222554072901092225547290109222554
07290109222455072901092224557290109222455

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

Regulatory Flags#

DUNS number
531857076
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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

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