FDA.reportPublic FDA data

VYGON

Primary DI
53660812112807
Brand
VYGON
Company
VYGON
Model
5382.06
Catalog number
5382.06
Device description
NeoSump Gastric Aspirator 06Fr Ø 1.2 x 2.0mm - L. 60cm
Published
2019-09-26
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

Product Codes#

Code, Name table
CodeName
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812112803PackageGS125In Commercial Distribution
53660812112807PackageGS14In Commercial Distribution
03660812112802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081211280333660812112803
5366081211280753660812112807
03660812112802036608121128023660812112802

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, sterileA sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
392994778
Device count
1
DM exempt
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253068762CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068779CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068809CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
00842071146412MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00842071146429MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00816340023162Transfer StrawNEODEVICES INCKNT2026-02-05
20885632464475HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-30
20197344200358MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200365MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200372MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200389MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20885632465069HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465076HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465083HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465106HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465113HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465120HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465137HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465144HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465175HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465281HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465335HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465342HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465380HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465434HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465465HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465489HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632464642HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464659HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464802HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22