Home GUDID 10857444006009 FLORIDA MEDICAL SALES INC.
Primary DI 10857444006009
Brand FLORIDA MEDICAL SALES INC.
Company FLORIDA MEDICAL SALES INC
Model FMSI-828
Catalog number H-FMSI- 828
Device description FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL PADS, 2 AA ALKALINE BATTERIES, 1 I.D. CARDS.
Published 2016-07-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name DRX Electrode, Electrocardiograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRX Electrode, Electrocardiograph Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10857444006009 Package GS1 20 In Commercial Distribution 00857444006002 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 10857444006009 10857444006009 00857444006002 00857444006002 857444006002 0857444006002
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.
Regulatory Flags# DUNS number 782049217 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857444006095 Florida Medical Sales, Inc. FMSI-836 H-FMSI- 836 2020-07-28 00857444006071 Florida Medical Sales, Inc. FMSI-835 H-FMSI- 835 2020-07-28 10857444006092 Florida Medical Sales, Inc. FMSI-836 H-FMSI- 836 2020-07-28 00857444006002 FLORIDA MEDICAL SALES INC. FMSI-828 H-FMSI- 828 2016-07-28 00857444006019 FLORIDA MEDICAL SALES INC. FMSI-832 H-FMSI- 832 2016-07-28 00857444006026 FLORIDA MEDICAL SALES INC. FMSI-833 H-FMSI- 833 2016-07-28 00857444006033 FLORIDA MEDICAL SALES FMSI-829 H-FMSI- 829 2016-07-28 00857444006040 FLORIDA MEDICAL SALES INC. FMSI-834 H-FMSI- 834 2016-07-29 00857444006057 FLORIDA MEDICAL SALES INC. FMSI-826 H-FMSI- 826 2016-08-22 10857444006016 FLORIDA MEDICAL SALES INC. FMSI-832 H-FMSI- 832 2016-07-28 10857444006023 FLORIDA MEDICAL SALES INC. FMSI-833 H-FMSI- 833 2016-07-28 10857444006030 FLORIDA MEDICAL SALES FMSI-829 H-FMSI- 829 2016-07-28 10857444006047 FLORIDA MEDICAL SALES INC. FMSI-834 H-FMSI- 834 2016-07-29 10857444006054 FLORIDA MEDICAL SALES INC. FMSI-826 H-FMSI- 826 2016-08-22
Other Devices Sharing Product Codes#