FDA.report

VACUETTE

Primary DI
39120126131012
Brand
VACUETTE
Company
Greiner Bio-One GmbH
Model
455043P
Catalog number
455043P
Device description
VACUETTE® TUBE 8.5 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Published
2024-07-02
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
39120126131012PackageGS124In Commercial Distribution
29120126131015PrimaryGS10
19120126131018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3912012613101239120126131012
2912012613101529120126131015
1912012613101819120126131018

GMDN Terms

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