BD Prevue II Peripheral Vascular Access System - BD Prevue II Console - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: BD Prevue II Console

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More Product Details

Catalog Number

9770700

Brand Name

BD Prevue II Peripheral Vascular Access System

Version/Model Number

9770700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

e521a046-024c-41e8-a182-0d2f7086d688

Public Version Date

August 24, 2021

Public Version Number

1

DI Record Publish Date

August 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BARD ACCESS SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 3348
U Unclassified 8