Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder - The KAWASUMI Multiple Sample Adapter with - SB-KAWASUMI LABORATORIES, INC.

Duns Number:690625850

Device Description: The KAWASUMI Multiple Sample Adapter with Pre-attached Holder is a sterile, single use dev The KAWASUMI Multiple Sample Adapter with Pre-attached Holder is a sterile, single use device consisting of a plastic holder with a non-patientcontacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used tocollect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huberneedle, etc. When blood is collected, the blood collection tube is placed over the cannula, pushing the rubber sheath back, allowing blood flow.When the blood collection tube is removed, the rubber sheath extends back over the cannula and stopping blood flow.

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More Product Details

Catalog Number

MBCH-01

Brand Name

Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder

Version/Model Number

MBCH-01

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

-

Product Code Details

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

f602bedc-51cd-4b7a-9165-c50ec83f9889

Public Version Date

April 15, 2022

Public Version Number

3

DI Record Publish Date

January 31, 2020

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