AccessGUDID - DEVICE: LIFEPAK CR Plus and LIFEPAK Express defibrillators (00883873820612)

GUDID

Device Identifier (DI) Information

Brand Name: LIFEPAK CR Plus and LIFEPAK Express defibrillators
Version or Model: 97403
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 97403-000004
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873820612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use
Previous DI: 00721902678387

Device Description: ASSY-LP CR PLUS,SEMI,SIGNS OF CIRCULATION

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?
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 [?]
P160012	000

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
Special Storage Condition, Specify: Storage at extreme temperatures of -40C to 70C (-40F to 158F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 35 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e19098ab-ef2f-4f6f-ad03-8494892d88d0
Public Version Date: May 20, 2020
Public Version Number: 2
DI Record Publish Date: May 01, 2019