Catalog Number

8318

Brand Name

Busse Hospital Disposables

Version/Model Number

8318

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

-

Product Code

LRS

Product Code Name

I.V. Start Kit

Public Device Record Key

29bd10cc-2624-4fce-9084-e2096e27d564

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

March 27, 2019

Package DI Number

10849233016047

Quantity per Package

50

Contains DI Package

00849233016040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-