FDA.reportPublic FDA data

INTERMITTENT INJECTION SITE

Primary DI
04987488104146
Brand
INTERMITTENT INJECTION SITE
Company
SB-KAWASUMI LABORATORIES, INC.
Model
INT-01
Catalog number
INT-01
Device description
The product is a simple injection/aspiration port which will be sold by itself. It terminates in a male luer taper which can be mated with any femail luer tapered lumen in a device, such as a catheter, communicating with blood or other body fluids. The port occludes the lumen of the catheter or other device. It also provides a latex septum for injection of fluids, including medication, or for aspiration of blood or fluids for testing, ETC. The septum is no-slitted. The Product is discarded when the main device is changed.This product comes with a luer protector cap which is removed and discarded before attaching the port to the catheter or device.This product is not specifically designed for use in hemodialysis systems.
Published
2024-12-06
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
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00646311500015PreviousGS10
04987488104146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646311500015006463115000156463115000150646311500015
04987488104146049874881041464987488104146

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

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
04987488102241PORT ACCESS INFUSION SETPI03090PI030902024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
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08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
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08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007208SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007215SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007222SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007239SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007253SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007284SOL CARE 1 DELTA MED SPAFOZ2021-03-30
08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005464Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005471Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005495Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26