FDA.reportPublic FDA data

BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR

Primary DI
00064631163003
Brand
BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR
Company
KAWASUMI LABORATORIES, INCORPORATED
Model
BK-64A
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00064631163003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00064631163003000646311630030646311630030064631163003

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. 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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