FDA.report

VYGON

Primary DI
53660812014637
Brand
VYGON
Company
VYGON
Model
2395.09
Catalog number
2395.09
Device description
Silicone gastro-duodenal feeding tube
Published
2016-09-09
Public version status
Update
Distribution status
Not 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
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
33660812014633PackageGS125Not in Commercial Distribution
53660812014637PackageGS124Not in Commercial Distribution
03660812014632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3366081201463333660812014633
5366081201463753660812014637
03660812014632036608120146323660812014632

GMDN Terms

TermDefinition
Nasoenteral tubeA sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. 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

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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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