AccessGUDID - DEVICE: LIFEPAK 1000 defibrillator (00883873815458)

GUDID

Device Identifier (DI) Information

Brand Name: LIFEPAK 1000 defibrillator
Version or Model: 99425
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99425-000023
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873815458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use
Previous DI: 00885074698878

Device Description: LP1000 CONFIGURED UNIT1000AAAAAAAACABAAAAAAAAA

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?
48049	Non-rechargeable professional 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, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated.	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 [?]
P160026	007

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
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Storage at extreme temperatures of -30C to 60C (-22F to 140F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a520c295-d9cb-4bda-8434-9263d73e021c
Public Version Date: May 18, 2020
Public Version Number: 2
DI Record Publish Date: April 12, 2019