FDA.reportPublic FDA data

BD Vacutainer® C&S Transfer Straw Kit

Primary DI
30382903649533
Brand
BD Vacutainer® C&S Transfer Straw Kit
Company
BECTON, DICKINSON AND COMPANY
Model
364953
Catalog number
364953
Device description
KIT URIN TRANSTR 13X75 4.0 C&S GR
Published
2020-11-16
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

Product Codes#

Code, Name table
CodeName
JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024240000BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITSBd2003-03-26JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382903649533PackageGS150In Commercial Distribution
50382903649537PrimaryGS10
00382903649532Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290364953330382903649533
5038290364953750382903649537
00382903649532003829036495323829036495320382903649532

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 Volume4Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
001292192
Device count
50
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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