FDA.reportPublic FDA data

Fresnius Kabi AG

Primary DI
10850038863040
Brand
Fresnius Kabi AG
Company
Directmed, Inc.
Model
FK20255E
Device description
"18"" Standard bore Extension Set with 1.2 Micron Filter, pinch clamp, male luer-lock and female luer"
Published
2023-10-31
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

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
10850038863040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085003886304010850038863040

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969484237
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
10850038863095Medaxis LLC2000.03012025-11-06
00850038863098Medaxis LLC2000.03012025-11-06
00850038863203Directmed, Inc.DM-1162025-07-11
10850038863200Directmed, Inc.DM-1162025-07-11
10850038863187Grace Medical, Inc.SP-30002024-11-18
10850038863194Grace Medical, Inc.SP-40002024-11-18
00850038863180Grace Medical, Inc.SP-30002024-11-18
00850038863197Grace Medical, Inc.SP-40002024-11-18
00850038863173Directmed, Inc.BMS-2135.172024-10-31
10850038863170Directmed, Inc.BMS-2135.172024-10-31
00850038863166DirectMed, Inc. SM-0072024-05-03
10850038863163DirectMed, Inc. SM-0072024-05-03
00850038863036Fresnius Kabi AGFK20251E2023-10-31
00850038863043Fresnius Kabi AGFK20255E2023-10-31
00850038863050Fresnius Kabi AGFK50030S2023-10-31
00850038863067Fresnius Kabi AGFK50060S2023-10-31
00850038863074OTOMED, INC.SP-30002023-10-31
00850038863081OTOMED, INC.SP-40002023-10-31
00850038863104Directmed, Inc.PME007B2023-10-31
00850038863111Directmed, Inc.PME007NB2023-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23