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

GMDN Terms#

Term, Definition table
TermDefinition
Culture medium antimicrobial supplement IVDA culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.

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
50382905167015BD Intelliport5167015167012020-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904453497BD BACTEC™ FXI Culture System Workflow ModuleBECTON, DICKINSON AND COMPANYMDB2026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer ModuleBECTON, DICKINSON AND COMPANYMDB2026-06-02
00382902451228BD BACTEC™ MGIT™ Mycobacteria Growth Indicator TubesBECTON, DICKINSON AND COMPANYMDB2026-01-07
00382904422882BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
60382904422884BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
00848838091841VersaTREK™ REMEL, INC.MDB2025-01-16
00848838091742VersaTREK™ REMEL, INC.MDB2025-01-16
00382904454753BD BACTEC™ 9240BECTON, DICKINSON AND COMPANYMDB2024-11-04
00382904455705BD BACTEC™ 9120BECTON, DICKINSON AND COMPANYMDB2024-11-04
60382904454755BD BACTEC™ 9240BECTON, DICKINSON AND COMPANYMDB2024-11-04
60382904455707BD BACTEC™ 9120BECTON, DICKINSON AND COMPANYMDB2024-11-04
00382904458003BD BACTEC™ 9050BECTON, DICKINSON AND COMPANYMDB2024-11-01
00382904458713BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
00382904459994BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
00382904413705BD BACTEC™ Digital ThermometerBECTON, DICKINSON AND COMPANYMDB2024-08-22
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00848838096518VERSATREK 240 W/8 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-26
00848838096549VERSATREK 240 W/10 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096556VERSATREK 240 W/10 DR/CTRL MOD 220VREMEL, INC.MDB2023-07-26
00848838096570VERSATREK 528 W/14 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096617 VERSATREK 528 W/16 DRAWERS/CTRL MOD REMEL, INC.MDB2023-07-26
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00848838096693VERSATREK 528 W/20 DRAWERS/CTRL MREMEL, INC.MDB2023-07-26
00848838096426VERSATREK 240 W/4 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-25
00848838096433 VERSATREK 240 W/4 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-25