Amplion Care Assurance - Care Assurance Station (CAS), Version 1.1 - AMPLION CLINICAL COMMUNICATIONS, INC.

Duns Number:626493555

Device Description: Care Assurance Station (CAS), Version 1.1

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More Product Details

Catalog Number

D-CAS-11-1

Brand Name

Amplion Care Assurance

Version/Model Number

D-CAS-11-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

IQA

Product Code Name

System, Environmental Control, Powered

Device Record Status

Public Device Record Key

e567e895-2158-402b-8e69-508dab8ec186

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMPLION CLINICAL COMMUNICATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 78