PMD-200 Single Use Sensor

Primary DI
07290017287201
Brand
PMD-200 Single Use Sensor
Company
MEDASENSE BIOMETRICS LTD
Model
MEK-0002
Catalog number
MEK-0002
Published
2023-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
07290017287027PackageGS120In Commercial Distribution
07290017287034PackageGS110In Commercial Distribution
07290017287201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017287027072900172870277290017287027
07290017287034072900172870347290017287034
07290017287201072900172872017290017287201

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 Temperature-10 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
532646234
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017287294PMD-200 Finger ProbeFP200-2PMD-FNP-212023-11-15
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
07290017287294PMD-200 Finger ProbeMEDASENSE 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