FDA.reportPublic FDA data

12 uPAT Probes for Watch-PAT

Primary DI
07290109222103
Brand
12 uPAT Probes for Watch-PAT
Company
ITAMAR MEDICAL LTD
Model
12 uPAT Probes for Watch-PAT
Catalog number
AC2101300
Device description
12 uPAT Probes
Published
2019-06-18
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
K133859000
K153070000
K161579000
K180775000
K203839000
K222331000

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
K180775000Watch-PAT300Itamar Medical , Ltd.2018-08-17MNR
K203839000WatchPAT200U (WP200U)Itamar Medical , Ltd.2022-03-21MNR
K222331000WatchPAT300 (WP300)Itamar Medical , Ltd.2022-09-14MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109222103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109222103072901092221037290109222103

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular-risk peripheral arterial tonometry system sensorAn pneumo-electronic device, typically designed as a proximal annular cuff incorporating plethysmography-based pneumatic bio-sensor, that is placed on a patient's finger during a reactive hyperemia test for the assessment of endothelial dysfunction (poor vasodilatory response) and arterial stiffness. It is connected to the cardiovascular-risk peripheral arterial tonometry system data processor and imparts a uniform pressure field to the distal two thirds of the finger, including the tip, to measure arterial pulsatile volume changes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure68.947 KiloPascal103.42 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure68.947 KiloPascal103.42 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature0 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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109222035Central Plus Sensor for Watch-PAT200UCentral Plus Sensor for Watch-PAT200UAC30001002017-05-15
07290109222059RESBP for Watch-PAT200URESBP for Watch-PAT200UAC30001012017-05-15
07290109222073Central Plus Sensor for Watch-PAT200UCentral Plus Sensor for Watch-PAT200UAC30001052018-05-23
07290109222080Central Plus Sensor for Watch-PAT200UCentral Plus Sensor for Watch-PAT200UUC30001002018-06-14
07290109222097Central Plus Sensor for Watch-PAT200UCentral Plus Sensor for Watch-PAT200UUC30001052018-06-14
0729010922281312 Adhesive Foam Disk 2side For Itamar SBP12 Adhesive Foam Disk 2side For Itamar SBPAC20001102016-09-07
07290109222837Tamper-Proof Bracelets (24), WatchPATTamper-Proof Bracelets (24), WatchPATAC20003002016-09-06
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720256698302Onera STS 2Onera B.V.MNR2026-05-15
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08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
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