FDA.reportPublic FDA data

MiniCollect

Primary DI
29120017578554
Brand
MiniCollect
Company
Greiner Bio-One GmbH
Model
450474
Catalog number
450474
Device description
MiniCollect® TUBE 1 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982999000GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBEGreiner Meditech, Inc.1998-10-16JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120017578551PackageGS110Not in Commercial Distribution
29120017578554PrimaryGS10
19120017578557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912001757855139120017578551
2912001757855429120017578554
1912001757855719120017578557

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood transfer tube IVD, EDTAA non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
303639066
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19120126131421VACUETTE4530494530492026-01-26
19120126131407VACUETTE4530474530472026-01-26
19120126131414VACUETTE4530484530482026-01-26
19120126131469VACUETTE4530464530462026-01-26
29120126131404VACUETTE4530474530472026-01-26
29120126131411VACUETTE4530484530482026-01-26
29120126131428VACUETTE4530494530492026-01-26
29120126131466VACUETTE4530464530462026-01-26
29120017577656Vacuette4588154588152020-09-24
19120126131452VACUETTE4530454530452025-04-02
29120126131459VACUETTE4530454530452025-04-02
29120049209310Vacuette4560084560082025-03-25
29120049209327Vacuette4550244550242025-03-25
29120049209334Vacuette4550234550232025-03-25
39120049209317Vacuette4560084560082025-03-25
39120049209324Vacuette4550244550242025-03-25
39120049209331Vacuette4550234550232025-03-25
19120126131001VACUETTE7243257243252024-07-23
29120126131008VACUETTE7243257243252024-07-23
29120049204605Vacuette455232P455232P2016-09-23

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