Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder MBCH-01

GUDID 00646311400292

The KAWASUMI Multiple Sample Adapter with Pre-attached Holder is a sterile, single use device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, 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.

KAWASUMI LABORATORIES, INCORPORATED

Blood collection set, noninvasive
Primary Device ID00646311400292
NIH Device Record Keyf602bedc-51cd-4b7a-9165-c50ec83f9889
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder
Version Model NumberMBCH-01
Catalog NumberMBCH-01
Company DUNS690625850
Company NameKAWASUMI LABORATORIES, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(813)630-5554
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100646311400292 [Primary]

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

Devices Manufactured by KAWASUMI LABORATORIES, INCORPORATED

00646311400292 - Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder2020-02-10The KAWASUMI Multiple Sample Adapter with Pre-attached Holder is a sterile, single use device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, 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.
00646311400292 - Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder2020-02-10 The KAWASUMI Multiple Sample Adapter with Pre-attached Holder is a sterile, single use device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, 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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