Nautilus Delta Port - PowerPort ClearVUE isp, 8F ChronoFlex Catheter, - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: PowerPort ClearVUE isp, 8F ChronoFlex Catheter, Intermediate NAUTILUS DELTA Kit

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More Product Details

Catalog Number

1608382

Brand Name

Nautilus Delta Port

Version/Model Number

1608382

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

f858c8ab-9110-4a25-a517-db0b4a2751c4

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

June 22, 2017

Additional Identifiers

Package DI Number

10801741136723

Quantity per Package

5

Contains DI Package

00801741136726

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