Dale Catheter Securement Device - Dale CVC, PICC and Arterial Sheath Catheter - DALE MEDICAL PRODUCTS, INC.

Duns Number:001061233

Device Description: Dale CVC, PICC and Arterial Sheath Catheter Securement Device Kit

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More Product Details

Catalog Number

853

Brand Name

Dale Catheter Securement Device

Version/Model Number

853

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)

-

Over the Counter (OTC)

Yes

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

40a3214c-32ec-4315-bb9c-ee54a62ab5f3

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

September 10, 2018

Additional Identifiers

Package DI Number

00817612020032

Quantity per Package

50

Contains DI Package

00817612020025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"DALE MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 74
2 A medical device with a moderate to high risk that requires special controls. 2