FDA.reportPublic FDA data

Acta Medical

Primary DI
00850033629590
Brand
Acta Medical
Company
Acta Medical LLC
Model
AMBFL0012
Device description
IV Admin Set Universal Spike and Drip Chamber, Roller Clamp, Slide Clamp, 1 NF Y Site, 1.2 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
00850033629590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033629590008500336295908500336295900850033629590

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
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
Primary DIBrandCompanyProduct codePublished
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
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