FDA.reportPublic FDA data

Vial Adapter RAYDYLYO

Primary DI
03701225770095
Brand
Vial Adapter RAYDYLYO
Company
UNION PLASTIC
Model
Ø20mm without filter
Catalog number
5MVA0006
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
K190816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190816000Vial Adapter Ø20 mm , Vial Adapter Ø13 mmAvenir Performance Europeenne Medical (Apem)2019-11-19LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701225770095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701225770095037012257700953701225770095

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
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
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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