AccessGUDID - DEVICE: CONMED (30653405006811)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 38-620-R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 38-620-R
Company Name: Conmed Corporation

Primary DI Number: 30653405006811
Issuing Agency: GS1
Commercial Distribution End Date: February 19, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ECG Leadwires

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:	Yes
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?
31683	Electrocardiographic lead switching adaptor	A switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	CABLE, ELECTRODE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K761301	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
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Handling Environment Temperature: between 5 and 35 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit
Handling Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d34e8369-a24a-4f48-b5a8-b90181c3a2ac
Public Version Date: August 20, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016