FLORIDA MEDICAL SALES H-FMSI- 829

GUDID 10857444006030

FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL PADS, 4 AA ALKALINE BATTERIES, 1 I.D. CARD.

FLORIDA MEDICAL SALES INC

Electrocardiographic long-term ambulatory recording support kit

• Primary Device ID: 10857444006030
• NIH Device Record Key: c2086336-9805-4a0c-9de9-b16f7ebac332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLORIDA MEDICAL SALES
• Version Model Number: FMSI-829
• Catalog Number: H-FMSI- 829
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00857444006033 [Primary]
GS1	10857444006030 [Package]; Contains: 00857444006033; Package: CASE [20 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-28

Devices Manufactured by FLORIDA MEDICAL SALES INC

• 00857444006071 - Florida Medical Sales, Inc.: 2020-08-05 1 PATIENT DIARY, 5 LEAD-LOK ELECTRODES, 1 PREP RAZOR, 1 TAPE CARD, 1 ALL PURPOSE SCRUB PAD AND 2 AAA ALKALINE BATTERIES
• 10857444006092 - Florida Medical Sales, Inc.: 2020-08-05 1 PATIENT DIARY, 5 LEAD-LOK ELECTRODES, AND 1 ALL PURPOSE SCRUB PAD
• 10857444006009 - FLORIDA MEDICAL SALES INC.: 2018-03-29 FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL PADS, 2 AA ALKALINE BATTERIES, 1
• 10857444006016 - FLORIDA MEDICAL SALES INC.: 2018-03-29 FMS HOLTER KIT-1PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 1 TAPE CARD, 1 ALL PURPOSE SCRUB PAD, 2 ALCOHOL PREPS, 2 AA ALKALINE
• 10857444006023 - FLORIDA MEDICAL SALES INC.: 2018-03-29 FMS HOLTER KIT - 1 PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 1 ALL PURPOSE SCRUB PAD, 2 ALCOHOL PREPS, 2 AA ALKALINE BATTERIES.
• 10857444006030 - FLORIDA MEDICAL SALES: 2018-03-29FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL PADS, 4 AA ALKALINE BATTERIES, 1 I.D. CARD.
• 10857444006030 - FLORIDA MEDICAL SALES: 2018-03-29 FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL PADS, 4 AA ALKALINE BATTERIES, 1 I
• 10857444006047 - FLORIDA MEDICAL SALES INC.: 2018-03-29 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.
• 10857444006054 - FLORIDA MEDICAL SALES INC.: 2018-03-29 FMS HOLTER KIT - STRESS KIT: 10 ELECTRODES, 1 RAZOR, 1 SCRUB PAD, AND 2 ALCOHOL PADS.