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

Duns Number:140727624

Device Description: L-Cath PICC S/L Peripherally Inserted Central Catheter 26Ga (1.9F) 0.60mm x 30cm

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More Product Details

Catalog Number

384539

Brand Name

L-Cath™ S/L PICC S/L

Version/Model Number

26GA (1.9F) x 30cm

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"

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

LJS

Product Code Name

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

Device Record Status

Public Device Record Key

57153105-c795-4815-924f-088c81e0616f

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

20886333209938

Quantity per Package

5

Contains DI Package

00886333209934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"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