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

Duns Number:140727624

Device Description: First PICC™ S/L Peripherally Inserted Central Catheter 22GA (2.8F) 0.95mm x 50cm with Stat First PICC™ S/L Peripherally Inserted Central Catheter 22GA (2.8F) 0.95mm x 50cm with Statlock® Stablization Device

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More Product Details

Catalog Number

384141

Brand Name

First PICC™ S/L Peripherally Inserted Central Catheter

Version/Model Number

384141

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

K972262,K972262

Product Code Details

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Device Record Status

Public Device Record Key

ef612c68-419a-47ce-afdc-aec8b1861317

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

20886333209662

Quantity per Package

5

Contains DI Package

00886333209668

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