FDA.reportPublic FDA data

MiniCollect

Primary DI
39120017578582
Brand
MiniCollect
Company
Greiner Bio-One GmbH
Model
450476
Catalog number
450476
Device description
MiniCollect® TUBE 0.25 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
39120017578582PackageGS110In Commercial Distribution
29120017578585PrimaryGS10
19120017578588Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912001757858239120017578582
2912001757858529120017578585
1912001757858819120017578588

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, K3EDTAA non-evacuated, non-sterile glass or plastic tube, sealed with a stopper, containing the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay determinations]. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303639066
Device count
100
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

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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