FDA.reportPublic FDA data

BD BACTEC™ Blood Culture Procedural Tray 2

Primary DI
30382904420018
Brand
BD BACTEC™ Blood Culture Procedural Tray 2
Company
BECTON, DICKINSON AND COMPANY
Model
442001
Catalog number
442001
Device description
BACTEC Blood Culture Procedural Tray 2
Published
2018-05-25
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904420018PackageGS120In Commercial Distribution
00382904420017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290442001830382904420018
00382904420017003829044200173829044200170382904420017

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

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
true
Combination product
true
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
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10382902212673BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)2212672212672016-12-21
30382903836483Nexiva3836483836482026-02-17
30382903810124Insyte Autoguard3810123810122026-02-13
30382903810230Insyte Autoguard3810233810232026-02-13
30382903810247Insyte Autoguard3810243810242026-02-13
30382903810339Insyte Autoguard3810333810332026-02-13
30382903810346Insyte Autoguard3810343810342026-02-13
30382903810377Insyte Autoguard3810373810372026-02-13
30382903810445Insyte Autoguard3810443810442026-02-13
30382903810476Insyte Autoguard3810473810472026-02-13
50382903810548Insyte Autoguard3810543810542026-02-13
50382903810579Insyte Autoguard3810573810572026-02-13
30382903818335Insyte Autoguard3818333818332026-02-13
30382903818373Insyte Autoguard3818373818372026-02-13
50382903818476Insyte Autoguard3818473818472026-02-13
30382903818540Insyte Autoguard3818543818542026-02-13
50382903818575Insyte Autoguard3818573818572026-02-13
50382903818674Insyte Autoguard3818673818672026-02-13
30382903819127Insyte Autoguard3819123819122026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00848838091742VersaTREK™ REMEL, INC.MDB2025-01-16
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
00382904427948BD BACTECTM Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2023-06-13
00848838096730VersaTREKREMEL, INC.MDB2022-12-22
30848838091828NAREMEL, INC.MDB2022-04-21
30848838091057NAREMEL, INC.MDB2021-12-27