FDA.reportPublic FDA data

VYGON

Primary DI
03660812073455
Brand
VYGON
Company
VYGON
Model
81363.062F
Catalog number
081363062F
Device description
Nutrisafe2 - Sonde de nutrition entérale - 06Fr - L.75cm - PUR (orange)
Published
2025-03-15
Public version status
New
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
FPDTUBE, FEEDING
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812073456PackageGS125In Commercial Distribution
53660812073450PackageGS124In Commercial Distribution
03660812073455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081207345633660812073456
5366081207345053660812073450
03660812073455036608120734553660812073455

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/non-ISO80369-standardized linear connectorA small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
392994778
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03660812123075VYGON5804.04005804042021-06-09
03660812123082VYGON5804.08005804082021-06-09
03660812141536VYGON115.11000115112023-08-24
03660812141567VYGON115.0900001150902023-07-03
03660812094535VYGON368.47000368472025-03-31
03660812106627VYGON1366.167100136616712025-03-31
03660812114844VYGON1366.067100136606712025-03-31
03660812118910VYGON1366.107100136610712025-03-31
03660812118927VYGON1366.107200136610722025-03-31
03660812118941VYGON1366.087100136608712025-03-31
03660812118958VYGON1366.087200136608722025-03-31
03660812126397VYGON1366.127100136612712025-03-31
03660812126403VYGON1366.127200136612722025-03-31
03660812145329VYGON1362.127200136212722025-03-31
03660812145923VYGON1362.107100136210712025-03-31
03660812145930VYGON1362.107200136210722025-03-31
03660812147088VYGON1366.147100136614712025-03-31
03660812154222VYGON1362.067100136206712025-03-31
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
10192253011210KangarooCardinal Health 200, LLCKNT2026-04-17
10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011333KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011456KangarooCardinal Health 200, LLCKNT2024-06-12
10192253011524KangarooCardinal Health 200, LLCKNT2024-05-23