Catalog Number

15071-000-0005

Brand Name

Bolus handle - US

Version/Model Number

15071-000-0005

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"

-

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

K192860,K192860,K192860,K192860

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

13c223c5-2e0b-4260-b54a-e3809040880f

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

27290109153975

Quantity per Package

42

Contains DI Package

17290109153978

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box