FDA.reportPublic FDA data

BD BACTEC™ Myco/F Lytic Culture Vials

Primary DI
60382904422884
Brand
BD BACTEC™ Myco/F Lytic Culture Vials
Company
BECTON, DICKINSON AND COMPANY
Model
442288
Catalog number
442288
Device description
BD BACTEC™ Myco/F Lytic Culture Vials
Published
2025-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K970333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970333000BACTEC MYCO/F LYTIC CULTURE VIALSBecton Dickinson Microbiology Systems1998-01-28MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904422883PackageGS150In Commercial Distribution
60382904422884PackageGS170In Commercial Distribution
00382904422882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290442288330382904422883
6038290442288460382904422884
00382904422882003829044228823829044228820382904422882

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
1
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382905167065BD Intelliport5167065167062020-09-30
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

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
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
00848838096747VERSATREK M 528 W/22 DRAWERSREMEL, INC.MDB2023-09-19
03573026629649BACT/ALERTBIOMERIEUX , INC.MDB2023-09-15
00848838096327VERSATREK 528 W/22 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096471VERSATREK 240 W/6 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-26
00848838096501VERSATREK 240 W/8 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
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
00848838096655VERSATREK 528 W/18 DRAWERS/CTRL MOD REMEL, INC.MDB2023-07-26
00848838096662VERSATREK 528 W/18 DR/CTRL MOD 220VREMEL, INC.MDB2023-07-26
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
30382904427949BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2023-06-13