PMD-200 Finger Probe

Primary DI
07290017287294
Brand
PMD-200 Finger Probe
Company
MEDASENSE BIOMETRICS LTD
Model
FP200-2
Catalog number
PMD-FNP-21
Published
2023-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QVEAdjunctive Pain Measurement Device For Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVEAdjunctive Pain Measurement Device For AnesthesiologyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210022000PMD-200Medasense Biometrics , Ltd.2023-02-17QVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017287249Direct MarkingGS10
07290017287294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017287249072900172872497290017287249
07290017287294072900172872947290017287294

GMDN Terms#

Term, Definition table
TermDefinition
Analgesia nociception index monitoring systemAn electrically-powered device designed to continuously detect and measure, noninvasively, pain-associated physiological parameters [e.g., heart rate, electrodermal activity (EDA), skin temperature] for the calculation and display of a nociceptive pain index value, typically to evaluate patient pain intensity for titration of analgesic medication during procedures involving anaesthesia. It consists of a bedside monitor with integrated software and skin surface sensors [e.g., photoplethysmograph, accelerometer, galvanic skin response (GSR) electrodes], typically placed on the patient’s finger.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
610-317-1670info@medasense.com

Regulatory Flags#

DUNS number
532646234
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017287201PMD-200 Single Use SensorMEK-0002MEK-00022023-11-15
07290017287348PMD-200 SystemPMD200-2SYS-1FP-232023-11-15
07290017287027PMD-200 Single Use SensorMEK-0002MEK-00022023-11-15
07290017287249PMD-200 Finger ProbeFP200-2PMD-FNP-212023-11-15
07290017287232PMD-200 SystemPMD200-2SYS-1FP-232023-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017287201PMD-200 Single Use SensorMEDASENSE BIOMETRICS LTDQVE2023-11-15
07290017287348PMD-200 SystemMEDASENSE BIOMETRICS LTDQVE2023-11-15
07290017287027PMD-200 Single Use SensorMEDASENSE BIOMETRICS LTDQVE2023-11-15
07290017287249PMD-200 Finger ProbeMEDASENSE BIOMETRICS LTDQVE2023-11-15
07290017287232PMD-200 SystemMEDASENSE BIOMETRICS LTDQVE2023-11-15