FDA.reportPublic FDA data

IV Administration Set

Primary DI
20876604000661
Brand
IV Administration Set
Company
Health Line International Corporation
Model
HLSV261822MB
Device description
IV Administration Set
Published
2017-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10876604000664PackageGS150In Commercial Distribution
20876604000661PackageGS14In Commercial Distribution
00876604000667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087660400066410876604000664
2087660400066120876604000661
00876604000667008766040006678766040006670876604000667

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed 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, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806251398
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00876604004603Synergy-XSA14-03160-03A14-031602023-05-24
00876604004627Synergy-XSA14-04260-03A14-042602023-05-24
00876604004634SynergyA14-05160-03A14-051602023-05-24
00876604004641SynergyA14-05260-03A14-052602023-05-24
00876604004658SynergyA14-06260-03A14-062602023-05-24
00876604004665SynergyA14-06360-03A14-063602023-05-24
00876604004672Synergy-XSA14-03160-N-03A14-03160-N2023-05-24
00876604004689Synergy-XSA14-04260-N-03A14-04260-N2023-05-24
00876604004696SynergyA14-05160-N-03A14-05160-N2023-05-24
00876604004702SynergyA14-06260-N-03A14-06260-N2023-05-24
00876604004719SynergyA14-06360-N-03A14-06360-N2023-05-24
00876604004726SynergyA14-05260-N-03A14-05260-N2023-05-24
00876604004733SynergyA14-04160-N-03A14-04160-N2023-05-24
00876604004740Synergy-XSA14-03160-IR-03A14-03160-IR2023-05-24
00876604004757SynergyA14-04160-IR-03A14-04160-IR2023-05-24
00876604004764Synergy-XSA14-04260-IR-03A14-04260-IR2023-05-24
00876604004788SynergyA14-05260-IR-03A14-05260-IR2023-05-24
00876604004795SynergyA14-06260-IR-03A14-06260-IR2023-05-24
00876604004801SynergyA14-06360-IR-03A14-06360-IR2023-05-24
10876604004600Synergy-XSA14-03160-03A14-031602023-05-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840010266Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010372Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010389Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
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04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
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