i-STAT - i-STAT ACT, CONTROL LEVEL 1 - ABBOTT POINT OF CARE INC.

Duns Number:079226216

Device Description: i-STAT ACT, CONTROL LEVEL 1

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More Product Details

Catalog Number

06P17-15

Brand Name

i-STAT

Version/Model Number

06P17-15

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

Yes

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

GGN

Product Code Name

PLASMA, COAGULATION CONTROL

Device Record Status

Public Device Record Key

b7c88466-6579-4f39-8011-ca1a2c0a3402

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT POINT OF CARE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 42
3 A medical device with high risk that requires premarket approval 14