FLORIDA MEDICAL SALES INC. H-FMSI- 828

GUDID 10857444006009

Electrocardiographic long-term ambulatory recording support kit

Primary Device ID	10857444006009
NIH Device Record Key	6fee26e5-2aea-4d0f-80f5-f4f83355ea6f
Commercial Distribution Status	In Commercial Distribution
Brand Name	FLORIDA MEDICAL SALES INC.
Version Model Number	FMSI-828
Catalog Number	H-FMSI- 828
Company DUNS	782049217
Company Name	FLORIDA MEDICAL SALES INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00857444006002 [Primary]
GS1	10857444006009 [Package] Contains: 00857444006002 Package: CASE [20 Units] In Commercial Distribution

DRX	Electrode, Electrocardiograph

Steralize Prior To Use	false
Device Is Sterile	false

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