FDA.reportPublic FDA data

BAXJECT II NTD

Primary DI
50642621003944
Brand
BAXJECT II NTD
Company
BAXALTA US INC.
Model
1505834
Catalog number
1505834
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042410000BAXJECT IIBaxter Healthcare Corp2004-10-08LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20642621003943PackageGS15In Commercial Distribution
50642621003944PackageGS120In Commercial Distribution
00642621003949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064262100394320642621003943
5064262100394450642621003944
00642621003949006426210039496426210039490642621003949

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079887619
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642621029239FlowEase [Subcutaneous] Infusion Set1M20061M20062016-09-28
00642621029246FlowEase [Subcutaneous] Infusion Set1M20091M20092016-09-28
00642621029253FlowEase [Subcutaneous] Infusion Set1M20121M20122016-09-28
00642621029383BAXJECT II Hi-Flow NTD3406013406012016-09-28
00642621003949BAXJECT II NTD150583415058342016-09-28
50642621029234FlowEase [Subcutaneous] Infusion Set1M20061M20062016-09-28
50642621029241FlowEase [Subcutaneous] Infusion Set1M20091M20092016-09-28
50642621029258FlowEase [Subcutaneous] Infusion Set1M20121M20122016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08699443581898FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581911FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581928FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585292FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585308FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585315FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585339FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
10815879021929IV PlusNEXUS MEDICAL, LLCLHI2025-10-03
10815879021806 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-10-21
08699443580174FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
10815879021783IV PlusNEXUS MEDICAL, LLCLHI2024-09-27
10815879021745IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
10815879021752IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
08699443580167FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-08-05
10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
10197344001699MedlineMEDLINE INDUSTRIES, INC.LHI2024-03-05
10815879021660IV PlusNEXUS MEDICAL, LLCLHI2024-03-05
10860009080505NavaClick Injection KitLineage Biomedical, Inc.LHI2024-01-30
10815879021547IV PlusNEXUS MEDICAL, LLCLHI2022-09-08
10193489896848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LHI2022-08-04
10815879021523IV PlusNEXUS MEDICAL, LLCLHI2022-06-15
10612479261959McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
10612479261973McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
08426314778770GRI-FILL 6 to1 SetLABORATORIOS GRIFOLS SALHI2021-10-25
10815879021394IV PlusNEXUS MEDICAL, LLCLHI2021-02-26
10815879021295IV PlusNEXUS MEDICAL, LLCLHI2021-01-20
10850022888011Vial2Bag Advanced 20mmWest Pharmaceutical Services Az, Inc.LHI2020-12-23
10813153020330CodanCodan US CorporationLHI2017-11-30
10813153020316CodanCodan US CorporationLHI2017-10-31