SecurAcath - INTERRAD MEDICAL, INC

Duns Number:555472310

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More Product Details

Catalog Number

400150

Brand Name

SecurAcath

Version/Model Number

6F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code Details

Product Code

KMK

Product Code Name

Device, Intravascular Catheter Securement

Device Record Status

Public Device Record Key

8612509b-7550-4b20-beba-896f23390caa

Public Version Date

June 04, 2020

Public Version Number

6

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

10865382000232

Quantity per Package

10

Contains DI Package

00865382000235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box

"INTERRAD MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6