FDA.reportPublic FDA data

K-SHIELD ADVANTAGE WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER

Primary DI
04987488103385
Brand
K-SHIELD ADVANTAGE WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER
Company
SB-KAWASUMI LABORATORIES, INC.
Model
DBMA-25G
Catalog number
DBMA-25G
Device description
The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter is used to access a patient's vein for blood sampling. The device incorporates an integral, active antineedle stick protector.
Published
2024-04-02
Public version status
New
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00646311400254PreviousGS10
04987488103385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646311400254006463114002546463114002540646311400254
04987488103385049874881033854987488103385

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge25Gauge

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
04987488111298K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03090PP030902026-05-31
04987488111304K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X90PP01X902026-05-31
04987488111311K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03091PP030912026-05-31
04987488111328K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X91PP01X912026-05-31
04987488111335K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03000PP030002026-05-31
04987488111342K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X00PP01X002026-05-31
04987488111359K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03001PP030012026-05-31
04987488111366K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X01PP01X012026-05-31
04987488111373K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03020PP030202026-05-31
04987488111380K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X20PP01X202026-05-31
04987488111397K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03021PP030212026-05-31
04987488111403K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X21PP01X212026-05-31
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

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