FDA.reportPublic FDA data

K-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter

Primary DI
04987488091200
Brand
K-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter
Company
SB-KAWASUMI LABORATORIES, INC.
Model
PBMA-25G
Catalog number
PBMA-25G
Device description
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.
Published
2023-06-28
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
04987488091200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987488091200049874880912004987488091200

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
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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