AllPoints Port Access System MiniLoc - AllPoints Port Access System MiniLoc 20G x 0.75 - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: AllPoints Port Access System MiniLoc 20G x 0.75 inch + BioPatch

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More Product Details

Catalog Number

AN632034B

Brand Name

AllPoints Port Access System MiniLoc

Version/Model Number

AN632034B

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

587c8299-a411-44d0-b9b1-7130643e3965

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

10801741215343

Quantity per Package

10

Contains DI Package

00801741215346

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"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