FDA.reportPublic FDA data

BD Vacutainer® Urinalysis Preservative Urine Tube

Primary DI
30382903650171
Brand
BD Vacutainer® Urinalysis Preservative Urine Tube
Company
BECTON, DICKINSON AND COMPANY
Model
365017
Catalog number
365017
Device description
TUBE URIN PLH 16X100 8.0 UAP PLBL YEL
Published
2023-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMHCONTAINER, SPECIMEN, STERILE
JTWSYSTEM, TRANSPORT, AEROBIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1
JTWSystem, Transport, AerobicMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790366000URINE CULTURE KITBd Becton Dickinson Vacutainer Systems Preanalytic1979-04-04JTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382903650171PackageGS1100In Commercial Distribution
50382903650175PrimaryGS10
00382903650170Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290365017130382903650171
5038290365017550382903650175
00382903650170003829036501703829036501700382903650170

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated urine specimen container IVD, preservativeA covered receptacle containing a pre-measured amount of vacuum and one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature4 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
001292192
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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