BACT/ALERT® SN - The BACT/ALERT SN Culture Bottles are used for - BIOMERIEUX , INC.

Duns Number:086785110

Device Description: The BACT/ALERT SN Culture Bottles are used for the recovery and detection of anaerobic and The BACT/ALERT SN Culture Bottles are used for the recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.

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More Product Details

Catalog Number

-

Brand Name

BACT/ALERT® SN

Version/Model Number

BACT/ALERT® SN

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K021123,K021123,K021123

Product Code Details

Product Code

MDB

Product Code Name

System, blood culturing

Device Record Status

Public Device Record Key

2911f085-75fc-4968-a85c-84354a46b22b

Public Version Date

April 29, 2020

Public Version Number

1

DI Record Publish Date

April 21, 2020

Additional Identifiers

Package DI Number

03573026611804

Quantity per Package

50

Contains DI Package

03573026595746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BIOMERIEUX , INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 75