AccessGUDID - DEVICE: EDGE SYSTEM (00883873784945)

GUDID

Device Identifier (DI) Information

Brand Name: EDGE SYSTEM
Version or Model: 11996
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11996-000091
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873784945
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use
Previous DI: 00721902195075

Device Description: EDGE System Electrodes with QUIK-COMBO Connector

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:	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?
44771	External defibrillation electrode, adult, single-use	An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) or back of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated external defibrillators (non-wearable)

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 Temperature: between 15 and 35 Degrees Celsius
Handling Environment Temperature: between -30 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 271a27b0-0213-4830-b016-b5f08f344aa2
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: November 03, 2020