Florida Medical Sales, Inc. H-FMSI- 836

GUDID 10857444006092

1 PATIENT DIARY, 5 LEAD-LOK ELECTRODES, AND 1 ALL PURPOSE SCRUB PAD

FLORIDA MEDICAL SALES INC

Electrocardiographic long-term ambulatory recording support kit

• Primary Device ID: 10857444006092
• NIH Device Record Key: 209dcf68-ca71-481c-8ea2-a17a39d73d52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Florida Medical Sales, Inc.
• Version Model Number: FMSI-836
• Catalog Number: H-FMSI- 836
• 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	00857444006095 [Primary]
GS1	10857444006092 [Package]; Contains: 00857444006095; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-05
• Device Publish Date: 2020-07-28

On-Brand Devices [Florida Medical Sales, Inc.]

• 10857444006092: 1 PATIENT DIARY, 5 LEAD-LOK ELECTRODES, AND 1 ALL PURPOSE SCRUB PAD
• 00857444006071: 1 PATIENT DIARY, 5 LEAD-LOK ELECTRODES, 1 PREP RAZOR, 1 TAPE CARD, 1 ALL PURPOSE SCRUB PAD AND 2