LIFENET ASSET EXPORT 64-BIT - LIFENET ASSET EXPORT 64-BIT 5.4.1.2 - PHYSIO-CONTROL, INC.

Duns Number:009251992

Device Description: LIFENET ASSET EXPORT 64-BIT 5.4.1.2

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More Product Details

Catalog Number

21340-000844

Brand Name

LIFENET ASSET EXPORT 64-BIT

Version/Model Number

21340

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 13, 2016

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

MSX

Product Code Name

SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

Device Record Status

Public Device Record Key

52e5a203-cc29-42ed-bc2d-716d3a30c91b

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

February 01, 2016

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