Catalog Number

15071-000-0005

Brand Name

Bolus - US

Version/Model Number

15071-000-0005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2017

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"

-

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

K123049,K123049,K123049

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

7bb6789a-2e8d-4ca0-8bf3-f2b6ec4be929

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

July 07, 2016

Package DI Number

27290109150035

Quantity per Package

42

Contains DI Package

17290109150038

Package Discontinue Date

March 03, 2017

Package Status

Not in Commercial Distribution

Package Type

cardboard box