V-Cath - 3.0Fr x 60cm Single Lumen PICC with Stylet and - NEO MEDICAL INC.

Duns Number:015510540

Device Description: 3.0Fr x 60cm Single Lumen PICC with Stylet and OTN Introducer

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More Product Details

Catalog Number

304-166

Brand Name

V-Cath

Version/Model Number

304-166

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K953300,K953300

Product Code Details

Product Code

LJS

Product Code Name

Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Device Record Status

Public Device Record Key

77426de4-1293-4cf2-8691-91cb8be85c35

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

B3393041665

Quantity per Package

10

Contains DI Package

B3393041660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NEO MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 88