FDA.reportPublic FDA data

12 uPAT Probes

Primary DI
07290109222103
Brand
12 uPAT Probes
Company
ITAMAR MEDICAL LTD
Model
12 uPAT Probes
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
OTC
false
Sterile
false
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 Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
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
true
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
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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