FDA.reportPublic FDA data

FLORIDA MEDICAL SALES INC.

Primary DI
00857444006040
Brand
FLORIDA MEDICAL SALES INC.
Company
FLORIDA MEDICAL SALES INC
Model
FMSI-834
Catalog number
H-FMSI- 834
Device description
FMS HOLTER KIT- 1 PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 2 TAPE CARDS, 1 ALL PURPOSE SCRUB PAD, 1 PATIENT ID, 1 AAA BATTERY.
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857444006047PackageGS120In Commercial Distribution
00857444006040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085744400604710857444006047
00857444006040008574440060408574440060400857444006040

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording support kitA 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
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857444006095Florida Medical Sales, Inc.FMSI-836H-FMSI- 8362020-07-28
00857444006071Florida Medical Sales, Inc.FMSI-835H-FMSI- 8352020-07-28
10857444006092Florida Medical Sales, Inc.FMSI-836H-FMSI- 8362020-07-28
00857444006002FLORIDA MEDICAL SALES INC.FMSI-828H-FMSI- 8282016-07-28
00857444006019FLORIDA MEDICAL SALES INC.FMSI-832H-FMSI- 8322016-07-28
00857444006026FLORIDA MEDICAL SALES INC.FMSI-833H-FMSI- 8332016-07-28
00857444006033FLORIDA MEDICAL SALESFMSI-829H-FMSI- 8292016-07-28
00857444006057FLORIDA MEDICAL SALES INC.FMSI-826H-FMSI- 8262016-08-22
10857444006009FLORIDA MEDICAL SALES INC.FMSI-828H-FMSI- 8282016-07-28
10857444006016FLORIDA MEDICAL SALES INC.FMSI-832H-FMSI- 8322016-07-28
10857444006023FLORIDA MEDICAL SALES INC.FMSI-833H-FMSI- 8332016-07-28
10857444006030FLORIDA MEDICAL SALESFMSI-829H-FMSI- 8292016-07-28
10857444006047FLORIDA MEDICAL SALES INC.FMSI-834H-FMSI- 8342016-07-29
10857444006054FLORIDA MEDICAL SALES INC.FMSI-826H-FMSI- 8262016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281501Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281525Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281532Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281549Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281587Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281600Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282829Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282881Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282966Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282980Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283017Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283024Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283048Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283055Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283062Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20