LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors - LP20E CONFIGURED - CMM,PACING, SPO2,ENGLISH - PHYSIO-CONTROL, INC.

Duns Number:009251992

Device Description: LP20E CONFIGURED - CMM,PACING, SPO2,ENGLISH

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More Product Details

Catalog Number

99507-000102

Brand Name

LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors

Version/Model Number

99507

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

fbe81fb5-62ed-486f-bd5c-ae2149da3e7c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 20, 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