KENAFLEXX - IV EXTENSION SET, 35" WITH FEMALE LUER CONNECTOR, - KENTRON HEALTHCARE, INC.

Duns Number:618825723

Device Description: IV EXTENSION SET, 35" WITH FEMALE LUER CONNECTOR, KEN_ROL MALE ROTATING LUER LOCK CONNECTO IV EXTENSION SET, 35" WITH FEMALE LUER CONNECTOR, KEN_ROL MALE ROTATING LUER LOCK CONNECTOR AND FLOW REGULATOR,

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More Product Details

Catalog Number

940035

Brand Name

KENAFLEXX

Version/Model Number

940035

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Device Record Status

Public Device Record Key

c94b1dba-0891-4895-8362-ada52409fd48

Public Version Date

December 19, 2018

Public Version Number

1

DI Record Publish Date

November 18, 2018

Additional Identifiers

Package DI Number

10852244007850

Quantity per Package

100

Contains DI Package

00852244007853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"KENTRON HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 155