FDA.reportPublic FDA data

nextaro® va, 15mm, 5µm

Primary DI
04063574200371
Brand
nextaro® va, 15mm, 5µm
Company
sfm medical devices GmbH
Model
20037
Device description
nextaro® va, 15mm (with 5µm filter for a 15mm vial)
Published
2024-09-11
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04063574200371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063574200371040635742003714063574200371

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, filteringA slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315549311
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04063574200425nextaro® va 13, 5 µm Filter200422025-09-05
04063574100008Cannula for subcutaneous Implant/ pellet administration100002021-09-23
04063574200401nextaro® v, 20/20, 5 µm 200402024-09-11
04063574200357nextaro® v, 20/32, 15 µm nominal200352024-06-05
04063574200272nextaro® v, 20/20, 15 µm nominal200272024-04-24
04063574200296nextaro® va883552023-08-17
04063574100022nextaro® va100022021-09-23
04063574200012nextaro®883532022-03-25
04063574100015nextaro®100012021-09-23
04063574848801Filter 20µm848802021-09-24

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Primary DI, Brand, Company table
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08699443585292FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
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08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
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10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
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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
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10813153020330CodanCodan US CorporationLHI2017-11-30