FDA.report

VACUETTE

Primary DI
29120126131008
Brand
VACUETTE
Company
Greiner Bio-One GmbH
Model
724325
Catalog number
724325
Device description
Urine Cup with integrated Transfer Device 100 ml 10 pcs./bag, sterile
Published
2024-07-23
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

Related Records

Product Codes

CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
29120126131008PackageGS110In Commercial Distribution
39120126131005PackageGS125In Commercial Distribution
19120126131001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2912012613100829120126131008
3912012613100539120126131005
1912012613100119120126131001

GMDN Terms

TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
303639066
Device count
1
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
true
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
39120049208754Vacuette450095V1450095V12023-12-07

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