AccessGUDID - DEVICE: LIFEPAK® 500 Automated External Defibrillator (00681490577526)

GUDID

Device Identifier (DI) Information

Brand Name: LIFEPAK® 500 Automated External Defibrillator
Version or Model: 99401
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99401-000146
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00681490577526
Issuing Agency: GS1
Commercial Distribution End Date: February 09, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: FINAL ASSY-LP500,ENGLISHVOICE,2 BUTTON OP

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:	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?
47910	Non-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. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.	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: 327eac80-5061-42ec-8c65-43ec288777e0
Public Version Date: May 30, 2019
Public Version Number: 3
DI Record Publish Date: November 11, 2014