FDA.reportPublic FDA data

SENSIMED Triggerfish® Recorder

Primary DI
07640153470133
Brand
SENSIMED Triggerfish® Recorder
Company
Sensimed SA
Model
R.V.4.1
Catalog number
ST5000
Device description
A small, battery operated electronic device that is used to operate the SENSIMED Triggerfish® Sensor and store the obtained data
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLZOcular Pattern Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLZOcular Pattern RecorderOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140017000SENSIMED TRIGGERFISHSensimed AG2016-03-04PLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640153470133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640153470133076401534701337640153470133

GMDN Terms#

Term, Definition table
TermDefinition
Ocular volume ambulatory recording system recorderAn electrically-powered component of an ocular volume ambulatory recording system intended to be used during daily activities and sleep (e.g., by patients at risk of glaucoma progression) to record data acquired by a sensor and transmitted by a transceiver. Recorded data is analysed and displayed by an off-the-shelf computing device (e.g., laptop) using dedicated software, to indicate patterns of intraocular pressure (IOP) fluctuation. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure23.62 Inches of Mercury31.3 Inches of Mercury
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure20.67 Inches of Mercury31.3 Inches of Mercury
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41216219191info@sensimed.ch

Regulatory Flags#

DUNS number
482491177
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640153470126SENSIMED Triggerfish® Recorder Sleeve004ST40012017-06-20
07640153470010SENSIMED Triggerfish® Sensor STEEPS.V.4ST10012017-06-20
07640153470027SENSIMED Triggerfish® Sensor MEDIUMM.V.4ST10022017-06-20
07640153470034SENSIMED Triggerfish® Sensor FLATF.V.4ST10032017-06-20
07640153470041SENSIMED Triggerfish® Sensor STEEPS.V.4BO3S2017-06-20
07640153470058SENSIMED Triggerfish® Sensor MEDIUMM.V.4BO3M2017-06-20
07640153470065SENSIMED Triggerfish® Sensor FLATF.V.4BO3F2017-06-20
07640153470072SENSIMED Triggerfish® Sensor SMFSMF.V.4BO3SMF2017-06-20
07640153470089SENSIMED Triggerfish® Antenna LEFTAL.3ST20012017-06-20
07640153470096SENSIMED Triggerfish® Antenna RIGHTAR.3ST20022017-06-20
07640153470102SENSIMED Triggerfish® Antenna LEFTAL.3BO3AL2017-06-20
07640153470119SENSIMED Triggerfish® Antenna RIGHTAR.3BO3AR2017-06-20
07640153470140SENSIMED Triggerfish® Data CableDC.V.5.1ST50102017-06-20
07640153470157SENSIMED Triggerfish® SoftwareV3ST80002017-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640153470010SENSIMED Triggerfish® Sensor STEEPSensimed SAPLZ2017-06-20
07640153470027SENSIMED Triggerfish® Sensor MEDIUMSensimed SAPLZ2017-06-20
07640153470034SENSIMED Triggerfish® Sensor FLATSensimed SAPLZ2017-06-20
07640153470041SENSIMED Triggerfish® Sensor STEEPSensimed SAPLZ2017-06-20
07640153470058SENSIMED Triggerfish® Sensor MEDIUMSensimed SAPLZ2017-06-20
07640153470065SENSIMED Triggerfish® Sensor FLATSensimed SAPLZ2017-06-20
07640153470072SENSIMED Triggerfish® Sensor SMFSensimed SAPLZ2017-06-20
07640153470089SENSIMED Triggerfish® Antenna LEFTSensimed SAPLZ2017-06-20
07640153470096SENSIMED Triggerfish® Antenna RIGHTSensimed SAPLZ2017-06-20
07640153470102SENSIMED Triggerfish® Antenna LEFTSensimed SAPLZ2017-06-20
07640153470119SENSIMED Triggerfish® Antenna RIGHTSensimed SAPLZ2017-06-20
07640153470126SENSIMED Triggerfish® Recorder SleeveSensimed SAPLZ2017-06-20
07640153470140SENSIMED Triggerfish® Data CableSensimed SAPLZ2017-06-20
07640153470157SENSIMED Triggerfish® SoftwareSensimed SAPLZ2017-06-20