AccessGUDID - DEVICE: Smart Trace Electrodes .060 in (B0361015663)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Trace Electrodes .060 in
Version or Model: 1015663
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1015663
Company Name: CIRCADIANCE, LLC

Primary DI Number: B0361015663
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012721295 *Terms of Use

Device Description: Smart Trace Electrodes .060 in., 10 Sets of 3

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):	No
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?
17460	Neonatal electrocardiographic electrode	A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). 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 [?]
K000206	000

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 Temperature: between 5 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7cf64503-1e16-4ede-ad14-a72a76f4a5d8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016