FDA.reportPublic FDA data

Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder

Primary DI
00646311400292
Brand
Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder
Company
SB-KAWASUMI LABORATORIES, INC.
Model
MBCH-01
Catalog number
MBCH-01
Device description
The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.
Published
2020-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00646311400292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646311400292006463114002926463114002920646311400292

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, noninvasiveA collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(813)630-5554info@kawasumiamerica.com

Regulatory Flags#

DUNS number
690625850
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04545499074423SB Knife Jr2MD-477022026-04-06
04545499074430SB Knife Jr2 /Long typeMD-47702L2026-04-06
00646311400018WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-21GDBM1-21G2016-09-20
00646311400025WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-23GDBM1-23G2016-09-20
00646311400032WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-25GDBM1-25G2016-09-20
00646311410017SMALL VEIN INFUSION SETD3K1-21G1D3K1-21G12016-09-20
00646311410024SMALL VEIN INFUSION SETD3K1-23G1D3K1-23G12016-09-20
00646311410031SMALL VEIN INFUSION SETD3K1-25G1D3K1-25G12016-09-20
00646311410055SMALL VEIN INFUSION SETD3K2-19GD3K2-19G2016-09-20
00646311410062SMALL VEIN INFUSION SETD3K2-20GD3K2-20G2016-09-20
00646311410079SMALL VEIN INFUSION SETD3K2-21GD3K2-21G2016-09-20
00646311410086SMALL VEIN INFUSION SETD3K2-22GD3K2-22G2016-09-20
00646311410093SMALL VEIN INFUSION SETD3K2-23GD3K2-23G2016-09-20
00646311410109SMALL VEIN INFUSION SETD3K2-24GD3K2-24G2016-09-20
00646311410116SMALL VEIN INFUSION SETD3K2-25GD3K2-25G2016-09-20
00646311410123SMALL VEIN INFUSION SETD3K2-27GD3K2-27G2016-09-20
00646311410482K-SHIELD ADVANTAGE SMALL VEIN INFUSION SETD3KA-19GD3KA-19G2016-09-20
00646311410505K-SHIELD ADVANTAGE SMALL VEIN INFUSION SETD3KA-27GD3KA-27G2016-09-20
04987488104139K-Shield Advantage Blood Drawing KitBK-64ABK-64A2024-12-24
04987488104146INTERMITTENT INJECTION SITEINT-01INT-012024-12-06

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