LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors - LP20E PACKAGE,PACING,ENGL,DOM - PHYSIO-CONTROL, INC.

Duns Number:009251992

Device Description: LP20E PACKAGE,PACING,ENGL,DOM

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More Product Details

Catalog Number

70507-000055

Brand Name

LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors

Version/Model Number

70507

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Device Record Status

Public Device Record Key

fd82e1d5-fc92-4c48-b4a8-2e7be8da1127

Public Version Date

May 09, 2019

Public Version Number

3

DI Record Publish Date

November 05, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHYSIO-CONTROL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 76
3 A medical device with high risk that requires premarket approval 588