Catalog Number

9770705

Brand Name

BD Prevue II Peripheral Vascular Access System

Version/Model Number

9770705

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

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

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

d055fa4f-43ea-4f8d-b03c-8dd2c880ebd0

Public Version Date

August 25, 2021

Public Version Number

1

DI Record Publish Date

August 17, 2021

Package DI Number

10801741222563

Quantity per Package

25

Contains DI Package

00801741222566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA