FDA.reportPublic FDA data

BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials

Primary DI
00382904420215
Brand
BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials
Company
BECTON, DICKINSON AND COMPANY
Model
442021
Catalog number
442021
Device description
BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDBSYSTEM, BLOOD CULTURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDBSystem, Blood CulturingMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123903000BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)Becton, Dickinson & CO2013-05-13MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904420216PackageGS150In Commercial Distribution
00382904420215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290442021630382904420216
00382904420215003829044202153829044202150382904420215

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume40Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Collection time
Special Storage Condition, Specify00Keep away from light
Special Storage Condition, Specify00Patient number
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
1
HCT/P
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903840120BD Introsyte Autoguard3840123840122016-10-20
00382903840083BD Introsyte-N Autoguard, BD Instaflash3840083840082016-10-20
00382903840106BD Introsyte Autoguard3840103840102016-10-20
00382903840113BD Introsyte Autoguard3840113840112016-10-20
50382903840217BD Introsyte-N, BD Instaflash3840213840212016-10-20
50382903840309BD Introsyte3840303840302016-10-20
50382903840316BD Introsyte-N3840313840312016-10-20
50382903840408BD Introsyte3840403840402016-10-20
50382903840507BD Introsyte3840503840502016-10-20
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay4411264411262018-05-25
00885403523437HemoSphere AltaALTAALL1ALTAALL12026-08-06
00885403523451HemoSphere AltaALTASR1ALTASR12026-08-06
00885403523475HemoSphere AltaALTACR1ALTACR12026-08-06
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24

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Primary DI, Brand, Company table
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00382902451228BD BACTEC™ MGIT™ Mycobacteria Growth Indicator TubesBECTON, DICKINSON AND COMPANYMDB2026-01-07
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