AccessGUDID - DEVICE: NOUN (00884838013056)

GUDID

Device Identifier (DI) Information

Brand Name: NOUN
Version or Model: TC ADDITIONAL LEADS KIT: IEC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803151761
Company Name: Philips Medical Systems Hsg

Primary DI Number: 00884838013056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Upgrade Kit 12-15/16 leads IECI color coded for PageWriter TC 70. Consisting of 4 additional lead assy (33", (0,84m)), 6 shorting plugs, 2 lead separators, 4 banana post adapters, 6 colored clips, 6 colored rings, 4 white base rings and instructions for use. The additional lead sets come pre-assembled with the 4 white base rings and the banana post adapter. 1 kit = 1 sales 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":	Yes
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
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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
Storage Environment Atmospheric Pressure: between 57.2 and 101.4 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90c4abd5-c59b-42ec-9e8a-b4858c21e9d5
Public Version Date: November 14, 2024
Public Version Number: 8
DI Record Publish Date: April 12, 2017