FDA.report

VYGON

Primary DI
53660812114580
Brand
VYGON
Company
VYGON
Model
800.01
Catalog number
00080001
Device description
Syringe adaptator - Raccord-réducteur seringue/sonde de petit diamètre - Luer-lock
Published
2021-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KYXDISPENSER, LIQUID MEDICATION

Product Code Classifications

CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
33660812114586PackageGS150In Commercial Distribution
53660812114580PackageGS148In Commercial Distribution
03660812114585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3366081211458633660812114586
5366081211458053660812114580
03660812114585036608121145853660812114585

GMDN Terms

TermDefinition
Luer/non-ISO80369-standardized linear connector, single-useA small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
392994778
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
false
Sterilization required before use
false

Other Devices From This Company

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33660812114845VYGON1366.067100136606712025-03-31
53660812118915VYGON1366.107100136610712025-03-31
53660812118922VYGON1366.107200136610722025-03-31
53660812118946VYGON1366.087100136608712025-03-31
33660812118959VYGON1366.087200136608722025-03-31
53660812126392VYGON1366.127100136612712025-03-31
33660812126404VYGON1366.127200136612722025-03-31
53660812145324VYGON1362.127200136212722025-03-31
33660812145924VYGON1362.107100136210712025-03-31
53660812145935VYGON1362.107200136210722025-03-31
33660812147089VYGON1366.147100136614712025-03-31
53660812154227VYGON1362.067100136206712025-03-31
53660812145317VYGON1362.127100136212712025-03-20
53660812166541VYGON363.1270003631272025-03-20
33660812064881VYGON5249.7210052497212025-03-15
33660812073388VYGON5557.4500055574502025-03-15
33660812073395VYGON5557.5500055575502025-03-15
53660812073450VYGON81363.062F081363062F2025-03-15

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