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.
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
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
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |