FDA.reportPublic FDA data

BD Microtainer® Tube Extender

Primary DI
50382903659765
Brand
BD Microtainer® Tube Extender
Company
BECTON, DICKINSON AND COMPANY
Model
365976
Catalog number
365976
Device description
BD Microtainer® Tube Extender
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection
NNICONTAINER, SPECIMEN, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
NNIContainer, Specimen, Non-SterilePathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931368000MICROTAINER BRAND TUBE WITH EDTABd Becton Dickinson Vacutainer Systems Preanalytic1993-09-28JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903659765PrimaryGS10
00382903659760Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290365976550382903659765
00382903659760003829036597603829036597600382903659760

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-use, non-sterileA non-sterile container (e.g., test tube, bottle, cup) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
200
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
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00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02

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