FLORIDA MEDICAL SALES INC. H-FMSI- 834

GUDID 10857444006047

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.

FLORIDA MEDICAL SALES INC

Electrocardiographic long-term ambulatory recording support kit
Primary Device ID10857444006047
NIH Device Record Key242da8a8-0ba6-40a9-af26-9ffdff82184e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLORIDA MEDICAL SALES INC.
Version Model NumberFMSI-834
Catalog NumberH-FMSI- 834
Company DUNS782049217
Company NameFLORIDA MEDICAL SALES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100857444006040 [Primary]
GS110857444006047 [Package]
Contains: 00857444006040
Package: CASE [20 Units]
In Commercial Distribution

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-29

On-Brand Devices [FLORIDA MEDICAL SALES INC.]

10857444006054FMS HOLTER KIT - STRESS KIT: 10 ELECTRODES, 1 RAZOR, 1 SCRUB PAD, AND 2 ALCOHOL PADS.
10857444006047FMS HOLTER KIT- 1 PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 2 TAPE CARDS, 1 ALL PURPOSE SCRUB P
10857444006023FMS HOLTER KIT - 1 PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 1 ALL PURPOSE SCRUB PAD, 2 ALCOHOL
10857444006016FMS HOLTER KIT-1PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 1 TAPE CARD, 1 ALL PURPOSE SCRUB PAD,
10857444006009FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL P

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