FDA.reportPublic FDA data

Vial Adapter MEDIC'UP

Primary DI
03701225770378
Brand
Vial Adapter MEDIC'UP
Company
UNION PLASTIC
Model
Ø20mm with filter 15µm syringe first
Catalog number
1MVA0031/3
Device description
Sterile Medical Device.Use for transfer and mixing of drugs contained in vials.
Published
2026-05-13
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
K190149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190149000Vial Adapter Ø20 mmAvenir Performance Europeenne Medical (Apem)2019-10-15LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701225770378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701225770378037012257703783701225770378

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
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
03701225770040Vial Adapter MEDIC'UPØ13mm filter 5µm1MVA00112024-03-07
03701225770057Vial Adapter MEDIC'UPØ13mm filter 15µm1MVA00142024-03-07
03701225770064Vial Adapter MEDIC'UPØ13mm without filter1MVA00042024-03-07

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