APEX™ - APEX, CONTROL MODULE, CAPS - ASSET - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: APEX, CONTROL MODULE, CAPS - ASSET

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More Product Details

Catalog Number

601228-99

Brand Name

APEX™

Version/Model Number

601228-99

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)

Yes

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

NEP

Product Code Name

SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Record Status

Public Device Record Key

b69d27b3-6e35-42f9-a878-d08dfab4bd41

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B. BRAUN MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 277
U Unclassified 2