Zyno

Primary DI
20814371020505
Brand
Zyno
Company
ZYNO MEDICAL LLC
Model
AX-80072-F
Catalog number
AX-80072-F
Device description
AX Administration Primary Set: 105" 2 NF Y-Site, 1 Below, 1 Above Pump, In-Line .22 Filter, Back Check-Valve. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX 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
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

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
10814371020508PackageGS150In Commercial Distribution
20814371020505PackageGS16In Commercial Distribution
00814371020501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081437102050810814371020508
2081437102050520814371020505
00814371020501008143710205018143710205010814371020501

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030899271
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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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