K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing

Primary DI
00646311552885
Brand
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing
Company
KAWASUMI LABORATORIES, INCORPORATED
Model
PH01X20
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
00646311552885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646311552885006463115528856463115528850646311552885

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690625850
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00646311400292Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached HolderMBCH-01MBCH-012020-01-31
00646311490026IV ADMINISTRATION SETIV-009Y2016-09-20
00646311490040IV ADMINISTRATION SETIV-013Y2016-09-20
00646311490057IV ADMINISTRATION SETIV-016Y2016-09-20
00646311490064IV ADMINISTRATION SETIV-020Y2016-09-20
00646311490088IV ADMINISTRATION SET WITH 22 MICRON FILTERIV-025Y2016-09-20
00646311490095IV ADMINISTRATION SET with Needleless Access ConnectorIV-009N2016-09-20
00646311490101IV ADMINISTRATION SET with Needleless Access ConnectorIV-013N2016-09-20
00646311490118IV ADMINISTRATION SET WITH 22 MICRON FILTER, NEEDLELESS ACCESS CONNECTORIV-025N2016-09-20
00646311490125IV ADMINISTRATION SET with Needleless Access ConnectorIV-020N2016-09-20
00646311490132IV ADMINISTRATION SET Secondary Administration SetIV-0192016-09-20
00646311490149IV ADMINISTRATION SETIV-017Y2016-09-20
00646311490156IV ADMINISTRATION SET with Needleless Access ConnectorIV-017N2016-09-20
00646311490163IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access ConnecIV-018N2016-09-20
00646311490187IV ADD-ON FILTER ADMINISTRATION SET WITH 22 MICRON FILTERIV-F02Y2016-09-20
00646311490217IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access ConnecIV-026N2016-09-20
00646311490224IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access ConnecIV-027N2016-09-20
00646311490255IV ADMINISTRATION SET with Needleless Access ConnectorIV-016N2016-09-20
00646311553080K-SHIELD ADVANTAGE PORT ACCESS INFUSION SETPA03090PA030902019-08-20
00646311553097K-SHIELD ADVANTAGE PORT ACCESS INFUSION SETPA01N90PA01N902019-08-20

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