Port Access Needle - Winged Infusion Set 22G x 0.75 inch with y-site - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: Winged Infusion Set 22G x 0.75 inch with y-site

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More Product Details

Catalog Number

2205222

Brand Name

Port Access Needle

Version/Model Number

2205222

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

8b76df58-1e7a-4e02-acd1-4b48089e1b2a

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

20801741065877

Quantity per Package

12

Contains DI Package

10801741065870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"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