BD Cathena™ Safety IV Catheter - US CATHENA 20GX2.00IN WINGED BC - BECTON, DICKINSON AND COMPANY

Duns Number:124987988

Device Description: US CATHENA 20GX2.00IN WINGED BC

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More Product Details

Catalog Number

386885

Brand Name

BD Cathena™ Safety IV Catheter

Version/Model Number

386885

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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"

Yes

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 Details

Product Code

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Device Record Status

Public Device Record Key

39c3bacf-b076-4ced-9108-16863eef5183

Public Version Date

November 15, 2021

Public Version Number

2

DI Record Publish Date

January 04, 2021

Additional Identifiers

Package DI Number

30382903868859

Quantity per Package

30

Contains DI Package

00382903868858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4