AccessGUDID - DEVICE: Model 3 (00856233005189)

GUDID

Device Identifier (DI) Information

Brand Name: Model 3
Version or Model: Unpackaged
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0104
Company Name: CARDIOCOMMAND, INC.

Primary DI Number: 00856233005189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800214827 *Terms of Use

Device Description: Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals, (unpackaged unit).

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
36719	Electrocardiographic signal amplifier	An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPA	System, Esophageal Pacing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P860008	018
P860008	022

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
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 40 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3f54fc1-84e5-4824-af24-6e349516b4c7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 03, 2015