FDA.reportPublic FDA data

Acta Medical

Primary DI
00850033629583
Brand
Acta Medical
Company
Acta Medical LLC
Model
AMBFL0011
Device description
IV Admin Set Universal Spike and Drip Chamber, Roller Clamp, Slide Clamp, 1 NF Y Site, 0.22 Micron Filter, Male Spin Luer Lock.
Published
2026-02-26
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
00850033629583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033629583008500336295838500336295830850033629583

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
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
00850033629033Acta MedicalAMA02502022-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
04046955836406Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
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
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
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