FDA.report

VYGON

Primary DI
33660812018693
Brand
VYGON
Company
VYGON
Model
5382.08
Catalog number
5382.08
Device description
NeoSump Gastric Aspirator
Published
2016-09-16
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
33660812018693PackageGS125Not in Commercial Distribution
53660812018697PackageGS14Not in Commercial Distribution
03660812018692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3366081201869333660812018693
5366081201869753660812018697
03660812018692036608120186923660812018692

GMDN Terms

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

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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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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