FDA.reportPublic FDA data

12 Adhesive Foam Disk 2side Itamar SBP for Watch-PAT200S3, Watch-PAT200U

Primary DI
07290109222813
Brand
12 Adhesive Foam Disk 2side Itamar SBP for Watch-PAT200S3, Watch-PAT200U
Company
ITAMAR MEDICAL LTD
Model
12 Adhesive Foam Disk 2side Itamar SBP for Watch-P
Catalog number
AC2000110
Device description
12 Adhesive Foam Disk 2side For Itamar SBP/RESBP
Published
2016-09-07
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109222813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109222813072901092228137290109222813

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.

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
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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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