FDA.reportPublic FDA data

Endo PAT 2000

Primary DI
07290109225395
Brand
Endo PAT 2000
Company
ITAMAR MEDICAL LTD
Model
Endo PAT 2000
Catalog number
US1650030
Device description
Endo PAT 2000 Device
Published
2017-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032519000ENDO PAT 2000Itamar Medical2003-11-12DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109225388PackageGS11In Commercial Distribution
07290109225395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109225388072901092253887290109225388
07290109225395072901092253957290109225395

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular-risk peripheral arterial tonometry systemAn electrically-powered assembly of devices designed to assess peripheral artery endothelial dysfunction (poor vasodilatory response) and/or arterial stiffness through the noninvasive measurement of arterial pulsatile volume changes in the fingertip during a reactive hyperemia test (occlusion of blood flow followed by abrupt release). It typically includes a dedicated bio-sensor applied to a finger or arm and a computer/software-controlled device used to process, store, display, and help analyse peripheral arterial tone (PAT) data received from the sensor. Endothelial dysfunction is a recognized marker of sub-clinical arteriosclerosis which is used as a predictor of cardiovascular events.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature22 Degrees Celsius24 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 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

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
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
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