FDA.reportPublic FDA data

Fresnius Kabi AG

Primary DI
00850038863043
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
00850038863043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038863043008500388630438500388630430850038863043

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
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
00850038863128HMG Distribution LLCCV12023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
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04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,Dynarex CorporationFPA2018-05-26
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