FDA.reportPublic FDA data

EndoPATx

Primary DI
07290109223377
Brand
EndoPATx
Company
ITAMAR MEDICAL LTD
Model
EndoPATx
Catalog number
US1650007
Device description
EndoPATx Device
Published
2023-04-27
Public version status
New
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
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211557000EndoPATxItamar Medical , Ltd.2022-12-29DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109223377PackageGS11In Commercial Distribution
07290109225432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109223377072901092233777290109223377
07290109225432072901092254327290109225432

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 Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature22 Degrees Celsius24 Degrees Celsius
Storage Environment Atmospheric Pressure57.2 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246177000infousa@zoll.com
1-888-748-2627itamar-support@zoll.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
0729010922210312 uPAT Probes12 uPAT ProbesAC21013002019-06-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
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00885403523512HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403523536HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403533764Smart Pressure ControllerBecton, Dickinson And CompanyDQK2026-09-18
00885403533771Smart Pressure Controller Accessory KitBecton, Dickinson And CompanyDQK2026-09-18
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQK2026-02-24
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