AccessGUDID - DEVICE: NA (30653405026314)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: RA36-05R-RED
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RA36-05R-RED
Company Name: Conmed Corporation

Primary DI Number: 30653405026314
Issuing Agency: GS1
Commercial Distribution End Date: June 08, 2022
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:	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?
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, breathing frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K912415	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 Temperature: between 5 and 35 Degrees Celsius
Handling Environment Temperature: between 41 and 95 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d459f4ab-24f7-443b-a935-1b98ef5e239f
Public Version Date: June 06, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016