Home GUDID 10851491007187
Lynn Medical - Ambulatory Kit
Primary DI 10851491007187
Brand Lynn Medical - Ambulatory Kit
Company Lynn Medical Instrument Co.
Model 311091
Catalog number 311091
Device description Ambulatory Monitoring Kit - Vermed A10091-5
Published 2018-10-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851491007187 Package GS1 200 In Commercial Distribution 20851491007184 Package GS1 100 In Commercial Distribution 30851491007181 Package GS1 20 In Commercial Distribution 00851491007180 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10851491007187 10851491007187 20851491007184 20851491007184 30851491007181 30851491007181 00851491007180 00851491007180 851491007180 0851491007180
GMDN Terms# Term, Definition table Term Definition Electrocardiographic long-term ambulatory recording support kit A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 10 Degrees Celsius 32 Degrees Celsius
Regulatory Flags# DUNS number 058810771 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company#