FDA.reportPublic FDA data

BD BACTEC™ 9120

Primary DI
60382904455707
Brand
BD BACTEC™ 9120
Company
BECTON, DICKINSON AND COMPANY
Model
445570
Catalog number
445570
Device description
BD BACTEC™ 9120
Published
2024-11-04
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
false

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
K922475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922475000BACTEC 9120 SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1992-07-01MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60382904455707PackageGS11In Commercial Distribution
00382904455705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6038290445570760382904455707
00382904455705003829044557053829044557050382904455705

GMDN Terms#

Term, Definition table
TermDefinition
Blood culture analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism. Changes in metabolite production which indicate growth may be detected using radiometric labelled substrate uptake, infrared spectrophotometric detection of CO2, fluorometric detection of fluorescent substrate uptake, photometric detection of turbidity change and/or colorimetric detection of pH induced colour change.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth22.5Centimeter
Height61Centimeter
Width132Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius30 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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

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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
00382904422882BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
60382904422884BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
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00382904454753BD BACTEC™ 9240BECTON, DICKINSON AND COMPANYMDB2024-11-04
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00382904458713BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
00382904459994BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
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30382904427949BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2023-06-13
00382904427948BD BACTECTM Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2023-06-13
00848838096730VersaTREKREMEL, INC.MDB2022-12-22