AccessGUDID - DEVICE: CHARGE-PAK™ Charging Unit & 2 QUIK-PAK Electrodes (00721902514111)

GUDID

Device Identifier (DI) Information

Brand Name: CHARGE-PAK™ Charging Unit & 2 QUIK-PAK Electrodes
Version or Model: 11403
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11403-000001
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00721902514111
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE

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:	Yes
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?
48045	Rechargeable public semi-automated external defibrillator	A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries for energy that must be charged when not in use.	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: e6e6b921-ca3a-47ce-acf8-6606781a1755
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 10, 2014