FDA.reportPublic FDA data

NeutrArt®

Primary DI
08699443585452
Brand
NeutrArt®
Company
ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
Model
UA1010NL20
Device description
Extension Set w/ Non-Bonded Needle-free Neutral Valve
Published
2022-04-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201872000NeutrArtAsset Medikal Tasarim As.2021-01-05FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28699443585456PackageGS150In Commercial Distribution
08699443585452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2869944358545628699443585456
08699443585452086994435854528699443585452

GMDN Terms#

Term, Definition table
TermDefinition
Neutral-pressure intravenous line needleless valve-connectorA small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(314) 961-5786cs@progressivemedinc.com
+1(800) 969-6331info@assetmedical.com

Regulatory Flags#

DUNS number
365581688
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810110920200IMed ProductsIM410572026-03-23
00810110920217IMed ProductsIM410582026-03-23
00810110920224IMed ProductsIM410592026-03-23
10810110920207IMed ProductsIM410572026-03-23
10810110920214IMed ProductsIM410582026-03-23
10810110920221IMed ProductsIM410592026-03-23
08699443581379FlowArt®A1010H2026-03-13
08699443583267NeutrArt®ATU3010N2026-03-13
28699443581373FlowArt®A1010H2026-03-13
28699443583261NeutrArt®ATU3010N2026-03-13
08699443582154NeutrArt®AU1010NL20R2026-02-16
28699443582158NeutrArt®AU1010NL20R2026-02-16
08699443581898FlowArt®AVV4028Y2026-02-13
08699443581911FlowArt®AVV40302026-02-13
08699443581928FlowArt®AVV4030Y2026-02-13
08699443585292FlowArt®AVV4020Y2026-02-13
08699443585308FlowArt®AVV40202026-02-13
08699443585315FlowArt®AVV40282026-02-13
08699443585322FlowArt®AVV4032Y2026-02-13
08699443585339FlowArt®AVV40322026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
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00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30