FDA.reportPublic FDA data

IMed Products

Primary DI
10810110920221
Brand
IMed Products
Company
ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
Model
IM41059
Device description
14" Bonded Extension Set, w / Needle-Free Neutral Valve
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K221481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221481000NeutrArtAsset Medikal Tasarim As.2022-09-23FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810110920221PackageGS150In Commercial Distribution
00810110920224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011092022110810110920221
00810110920224008101109202248101109202240810110920224

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)969-6331info@assetmedical.com

Regulatory Flags#

DUNS number
365581688
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
28699443581892FlowArt®AVV4028Y2026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
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
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624601253Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921207Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921214Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921238Q2 Blood Administration SetsQUEST MEDICAL INCFPA2022-12-06
00634624921122High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-06
00634624921115High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-05
00634624911062Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-10-26
00634624921382Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921399Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921405Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921412Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921429Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921436Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921016Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921023Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921030Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921061Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921078Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624922044Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24