FDA.reportPublic FDA data

Vial Adapter MEDIC'UP

Primary DI
03701225770040
Brand
Vial Adapter MEDIC'UP
Company
UNION PLASTIC
Model
Ø13mm filter 5µm
Catalog number
1MVA0011
Device description
Sterile Medical DeviceUse for the transfer and mixing of drugs contained in vials
Published
2024-03-07
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

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
K220856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220856000Vial Adapter Ø13mmAvenir Performance Européenne Medical (Apem)2022-06-21LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701225770040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701225770040037012257700403701225770040

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
Radiation Sterilization

Regulatory Flags#

DUNS number
381128396
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701225770095Vial Adapter RAYDYLYOØ20mm without filter5MVA00062026-05-13
03701225770125Vial Adapter RAYDYLYOØ13mm without filter5MVA00162026-05-13
03701225770163Vial Adapter MEDIC'UPØ13mm without filter1MVA0004/32026-05-13
03701225770187Vial Adapter MEDIC'UPØ20mm with filter 15µm syringe first1MVA00312026-05-13
03701225770224Vial Adapter MEDIC'UPØ20mm without filter1MVA0017/12026-05-13
03701225770231Vial Adapter MEDIC'UPØ20mm with filter 5µm1MVA0008/12026-05-13
03701225770255Vial Adapter MEDIC'UPØ13mm with filter 5µm1MVA0011/32026-05-13
03701225770286Vial Adapter MEDIC'UPØ20mm with filter 5µm1MVA0043/12026-05-13
03701225770378Vial Adapter MEDIC'UPØ20mm with filter 15µm syringe first1MVA0031/32026-05-13
03701225770392Vial Adapter MEDIC'UPØ20mm with filter 5µm1MVA0008/22026-05-13
03701225770408Vial Adapter MEDIC'UPØ20mm with filter 5µm1MVA0043/22026-05-13
03701225770149Vial Adapter MEDIC'UPØ13mm without filter1MVA0004/12024-06-27
03701225770156Vial Adapter MEDIC'UPØ13mm without filter1MVA0004/22024-06-27
03701225740845Vaginal Applicator APPLISILApplicator 2.5g - Flowpack by 11ASV11552024-03-07
03701225770019Vial Adapter MEDIC'UPØ20mm filter 5µm1MVA00082024-03-07
03701225770026Vial Adapter MEDIC'UPØ20mm filter 15µm1MVA00202024-03-07
03701225770033Vial Adapter MEDIC'UPØ20mm without filter1MVA00172024-03-07
03701225770057Vial Adapter MEDIC'UPØ13mm filter 15µm1MVA00142024-03-07
03701225770064Vial Adapter MEDIC'UPØ13mm without filter1MVA00042024-03-07

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