K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing - SB-KAWASUMI LABORATORIES, INC.

Duns Number:690625850

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More Product Details

Catalog Number

-

Brand Name

K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing

Version/Model Number

PH01X91

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 2019

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)

-

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

ced1e1d2-d51f-4de0-8f3d-cdb4ef986ec0

Public Version Date

April 15, 2022

Public Version Number

6

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SB-KAWASUMI LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 211