FDA.reportPublic FDA data

Zyno

Primary DI
00814371020389
Brand
Zyno
Company
ZYNO MEDICAL LLC
Model
FE04
Catalog number
FE04
Device description
"Extension Set: 14"" In-Line 1.2 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration setsfor use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All extension 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
10814371020386PackageGS150In Commercial Distribution
20814371020383PackageGS16In Commercial Distribution
00814371020389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081437102038610814371020386
2081437102038320814371020383
00814371020389008143710203898143710203890814371020389

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.

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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