Home GUDID 10851491007293
Lynn Medical - Ambulatory Kit
Primary DI 10851491007293
Brand Lynn Medical - Ambulatory Kit
Company Lynn Medical Instrument Co.
Model 311235
Catalog number 311235
Device description Ambulatory Monitoring Kit - Kendall 235
Published 2018-10-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851491007293 Package GS1 10 In Commercial Distribution 20851491007290 Package GS1 50 In Commercial Distribution 30851491007297 Package GS1 20 In Commercial Distribution 00851491007296 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 10851491007293 10851491007293 20851491007290 20851491007290 30851491007297 30851491007297 00851491007296 00851491007296 851491007296 0851491007296
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#