FDA.report

VACUETTE

Primary DI
39120126130992
Brand
VACUETTE
Company
Greiner Bio-One GmbH
Model
486089
Catalog number
486089
Device description
VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, G-barcode label, non-ridged
Published
2024-05-14
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
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions

SubmissionSupplement
K960858000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K960858000GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATORGreiner America, Inc.1996-08-30JKA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
39120126130992PackageGS124In Commercial Distribution
29120126130995PrimaryGS10
19120126130998Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3912012613099239120126130992
2912012613099529120126130995
1912012613099819120126130998

GMDN Terms

TermDefinition
Evacuated blood collection tube IVD, clot activatorA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and a clot activator. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum chemistry determinations). 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
50
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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