FDA.report

Vacuette

Primary DI
39120049200987
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
459010
Catalog number
459010
Device description
VACUETTE® SECONDARY Tube MULTIPLEX PP 13x75 mm without cap, PREMIUM
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NNICONTAINER, SPECIMEN, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
39120049200987PackageGS14In Commercial Distribution
29120049200980PrimaryGS10
19120049200983Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3912004920098739120049200987
2912004920098029120049200980
1912004920098319120049200983

GMDN Terms

TermDefinition
General laboratory container, single-use, non-sterileA non-sterile container (e.g., test tube, bottle, cup) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-80 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
303639066
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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29120049208726Vacuette450082V1450082V12023-12-07
29120049208740Vacuette450084V1450084V12023-12-07

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