L-Cath S/L PICC S/L - Peripherally Inserted Central Catheter - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Peripherally Inserted Central Catheter

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More Product Details

Catalog Number

384465

Brand Name

L-Cath S/L PICC S/L

Version/Model Number

18GA (5F) 1.65mm x 60cm

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

LJS

Product Code Name

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

Device Record Status

Public Device Record Key

239d7b5a-ac4e-46ae-ab7d-4c28a22f5e1a

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

20886333209846

Quantity per Package

5

Contains DI Package

00886333209842

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205