AccessGUDID - DEVICE: FLORIDA MEDICAL SALES INC. (00857444006057)

GUDID

Device Identifier (DI) Information

Brand Name: FLORIDA MEDICAL SALES INC.
Version or Model: FMSI-826
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H-FMSI- 826
Company Name: FLORIDA MEDICAL SALES INC

Primary DI Number: 00857444006057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 782049217 *Terms of Use

Device Description: FMS HOLTER KIT - STRESS KIT: 10 ELECTRODES, 1 RAZOR, 1 SCRUB PAD, AND 2 ALCOHOL PADS.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62149	Electrocardiographic long-term ambulatory recording support kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b9b0b62a-8d1d-4235-bb41-d3c37f84115a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 22, 2016