FDA.reportPublic FDA data

K-SHIELD PHLEBOTOMY SET WITH ANTINEEDLE STICK PROTECOTR

Primary DI
00646311620010
Brand
K-SHIELD PHLEBOTOMY SET WITH ANTINEEDLE STICK PROTECOTR
Company
KAWASUMI LABORATORIES, INCORPORATED
Model
BO-1000
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00646311620010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646311620010006463116200106463116200100646311620010

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

Contacts#

Phone, Email table
PhoneEmail
(813) 630-5554info@kawasumiamerica.com

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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Primary DI, Brand, Company table
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00827989007987Venting NeedleHealth Care Logistics, Inc.LHI2026-03-04
28699443581892FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443581915FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443581922FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585296FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585302FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585319FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585326FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585333FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
00827989007826SuregripHealth Care Logistics, Inc.LHI2025-12-19
00827989007833SuregripHealth Care Logistics, Inc.LHI2025-12-19
00850025688291HyHub Vial Access DeviceTakeda Pharmaceuticals U.S.A., Inc.LHI2025-09-23
00850025688963HyHub Duo Vial Access DeviceTakeda Pharmaceuticals U.S.A., Inc.LHI2025-09-23
04063574200425nextaro® va 13, 5 µm Filtersfm medical devices GmbHLHI2025-09-05
20851891007609ArisureYUKON MEDICAL, LLCLHI2025-06-30
20851891007623ArisureYUKON MEDICAL, LLCLHI2025-05-23
10851891007299ArisureYUKON MEDICAL, LLCLHI2025-05-14
10851891007305ArisureYUKON MEDICAL, LLCLHI2025-05-14
10810110921389Mini Transfer PinMPS Pharma & Medical, Inc.LHI2025-04-28
10887709128009ICU Medical, Inc.ICU MEDICAL, INC.LHI2025-04-25
00860007260421IVX Station Reconstitution Transfer SetOmnicell, Inc.LHI2025-01-23
10851891007329ArisureYUKON MEDICAL, LLCLHI2024-11-27
10851891007350ArisureYUKON MEDICAL, LLCLHI2024-11-27
00347426505086ZYNRELEF 10 mL Vial Access Needle (VAN) ReplacementHeron Therapeutics, Inc.LHI2024-11-07
00347426506083ZYNRELEF 20 mL Vial Access Needle (VAN) ReplacementHeron Therapeutics, Inc.LHI2024-11-07
28699443580178FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
30815879021749IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
30815879021756IV PlusNEXUS MEDICAL, LLCLHI2024-09-16