Pressure Monitoring Lines - Pressure Monitoring Lines 24" Red Injection Line - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Pressure Monitoring Lines 24" Red Injection Line w/Male & Female Luer Lock Connectors

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More Product Details

Catalog Number

040302005A

Brand Name

Pressure Monitoring Lines

Version/Model Number

040302005A

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

K781558,K781558

Product Code Details

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Device Record Status

Public Device Record Key

26c72113-8b08-4186-a03e-cb1bb3863e74

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

20886333201277

Quantity per Package

25

Contains DI Package

00886333201273

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