MULTITECH 3G GATEWAY - ATT KORE - MULTITECH 3G GATEWAY - ATT KORE - PHYSIO-CONTROL, INC.

Duns Number:009251992

Device Description: MULTITECH 3G GATEWAY - ATT KORE

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More Product Details

Catalog Number

21996-000105

Brand Name

MULTITECH 3G GATEWAY - ATT KORE

Version/Model Number

21996

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2016

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"

-

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

9bcd518c-aca6-4b4e-ba7c-87e9f2f03213

Public Version Date

April 06, 2020

Public Version Number

3

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