ABBOTT PRISM - ABBOTT PRISM Activator Concentrate - ABBOTT LABORATORIES

Duns Number:079226220

Device Description: ABBOTT PRISM Activator Concentrate

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More Product Details

Catalog Number

01A7502

Brand Name

ABBOTT PRISM

Version/Model Number

1A75-02

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

17cf856d-37fe-406e-bfed-306f0957d97f

Public Version Date

January 13, 2022

Public Version Number

4

DI Record Publish Date

January 31, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT LABORATORIES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 259
2 A medical device with a moderate to high risk that requires special controls. 245
U Unclassified 5