AccessGUDID - DEVICE: EDGE Electrodes with REDI-PAK™ Preconnect System (00681490580656)

GUDID

Device Identifier (DI) Information

Brand Name: EDGE Electrodes with REDI-PAK™ Preconnect System
Version or Model: 11996
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11996-000017
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00681490580656
Issuing Agency: GS1
Commercial Distribution End Date: November 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: ELECT ASSY-EDGE,QUIK-COMBO REDI-PAK,WW

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1dd95b69-a216-41d9-a139-2faf552f5000
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: November 10, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40681490580654	50	20681490580650	2020-11-02	Not in Commercial Distribution	Case
20681490580650	10	00681490580656	2020-11-02	Not in Commercial Distribution	Shelf Pak