Catalog Number

BC10969

Brand Name

AIV

Version/Model Number

BC10969

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2019

Issuing Agency

In HIBCC

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

K120209

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

eb8c2d4f-3cfa-4692-86c7-91e1fb87a330

Public Version Date

September 26, 2019

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-