FDA.reportPublic FDA data

Acta Medical

Primary DI
00850033629217
Brand
Acta Medical
Company
Acta Medical LLC
Model
AMBFL003
Device description
IV Admin set 1 NF Y Site
Published
2022-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033629217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033629217008500336292178500336292170850033629217

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117299766
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033629439Acta MedicalACTAPPS003LPV2026-02-26
00850033629446Acta MedicalACTAMIX0150ACTAMIX01502026-02-26
00850033629583Acta MedicalAMBFL00112026-02-26
00850033629590Acta MedicalAMBFL00122026-02-26
00850033629330Acta MedicalACTA2P0100ACTA2P01002025-03-17
00850033629347Acta MedicalACTA2P0250ACTA2P02502025-03-17
00850033629354Acta MedicalACTA2P0500ACTA2P05002025-03-17
00850033629361Right Way MedicalRWM-5002RWM-50022025-03-17
00850033629378Right Way MedicalRWM-10002RWM-100022025-03-17
00850033629408Acta MedicalACTAPPS003WC2024-02-14
00850033629149Acta MedicalACTAPPS0012022-08-11
00850033629156Acta MedicalACTAPPS003W2022-08-11
00850033629163Acta MedicalACTAPPS0032022-08-11
00850033629170Acta MedicalACTAPPS-TRI2022-08-11
00850033629187Acta MedicalACTAPST0012022-08-11
00850033629194Acta MedicalACTAPST003W2022-08-11
00850033629385Caretech286022EA2023-09-07
00850033629002Acta MedicalAMA01052022-08-11
00850033629019Acta MedicalAMA0150HS2022-08-11
00850033629026Acta MedicalAMA0150HSV2022-08-11

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