FDA.reportPublic FDA data

Zyno

Primary DI
00814371020556
Brand
Zyno
Company
ZYNO MEDICAL LLC
Model
BX-70071-DF-120
Catalog number
BX-70071-DF-120
Device description
"BX Administration Primary Set: 105"" 1 NF Y Site Below Pump, 1.2 Filter, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
Published
2016-09-23
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120685000ZYNO MEDICAL ADMINISTRATION SETZyno Medical, LLC2012-09-07FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814371020553PackageGS150In Commercial Distribution
20814371020550PackageGS16In Commercial Distribution
00814371020556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081437102055310814371020553
2081437102055020814371020550
00814371020556008143710205568143710205560814371020556

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Regulatory Flags#

DUNS number
030899271
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
00814371020013Z-800FZ-800FZ-800F2015-10-13
00814371020020Z-800WZ-800WZ-800W2015-10-13
00814371020037Z-800WFZ-800WFZ-800WF2015-10-13
00814371020044NimbusNimbusNimbus2015-10-13
00814371020006Z-800Z-800Z-8002015-10-13
10814371020058ZynoA2-80070A2-800702016-09-23
10814371020065ZynoA2-80071-DA2-80071-D2016-09-23
10814371020072ZynoA2-80071-DFA2-80071-DF2016-09-23
10814371020089ZynoA2-80071-DF120A2-80071-DF1202016-09-23
10814371020096ZynoA2-80071-PA2-80071-P2016-09-23
10814371020102ZynoA2-80071-PFA2-80071-PF2016-09-23
10814371020119ZynoA2-80072A2-800722016-09-23
10814371020126ZynoA2-80072-FA2-80072-F2016-09-23
10814371020133ZynoA2-80075A2-800752016-09-23
10814371020140ZynoB2-70070B2-700702016-09-23
10814371020157ZynoB2-70071-DB2-70071-D2016-09-23
10814371020164ZynoB2-70071-DFB2-70071-DF2016-09-23
10814371020171ZynoB2-70071-DF120B2-70071-DF1202016-09-23
10814371020188ZynoB2-70071-PB2-70071-P2016-09-23
10814371020195ZynoB2-70072B2-700722016-09-23

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Primary DI, Brand, Company table
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05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
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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
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
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
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06