ACS - BLOOD CULTURE KIT NON-STERILE - AMERICAN CONTRACT SYSTEMS, INC.

Duns Number:010334675

Device Description: BLOOD CULTURE KIT NON-STERILE

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More Product Details

Catalog Number

-

Brand Name

ACS

Version/Model Number

MHBC03C

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

OIB

Product Code Name

Blood And Urine Collection Kit (Excludes Hiv Testing)

Device Record Status

Public Device Record Key

ee4a39be-ea16-40bc-9f6a-2363dec97b94

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN CONTRACT SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3339
2 A medical device with a moderate to high risk that requires special controls. 13185