FDA.reportPublic FDA data

BD Phoenix™ PMIC-107

Primary DI
30382904484171
Brand
BD Phoenix™ PMIC-107
Company
BECTON, DICKINSON AND COMPANY
Model
448417
Catalog number
448417
Device description
BD Phoenix™ PMIC-107
Published
2016-05-19
Public version status
Update
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
LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904484171PrimaryGS10
00382904484170Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290448417130382904484171
00382904484170003829044841703829044841700382904484170

GMDN Terms#

Term, Definition table
TermDefinition
Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to determine the identification and antimicrobial susceptibility profile of gram positive bacteria species isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 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
25
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904450106BD Veritor™ InfoWiFi Module4450104450102026-03-13
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
00382904490850NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
15099590799717MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799724MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799755MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799762MicroScanBeckman Coulter, Inc.LON2025-12-17
03573026615499VITEK® COMPACT PROBIOMERIEUX , INC.LON2025-05-15
03573026618285VITEKBIOMERIEUX , INC.LON2025-05-15
00382904449575BDXpert™ SystemBECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490829NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490836NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
10850031114026Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LON2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LON2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
10850031114149Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00850031114135Selux AST Gram Positive PanelsSelux Diagnostics, Inc.LON2024-12-17
03573026641337VITEK® 2 AST-N815BIOMERIEUX , INC.LON2024-11-13
00382904490362Panel Phoenix PMIC-110BECTON, DICKINSON AND COMPANYLON2024-08-29
00382904494520BD Phoenix™ NMIC-311BECTON, DICKINSON AND COMPANYLON2024-08-29
03573026636357VITEK® 2 AST-N814BIOMERIEUX , INC.LON2023-12-06
03573026635978VITEK® 2 AST-N809BIOMERIEUX , INC.LON2023-11-02
03573026636142VITEK® 2 AST-N811BIOMERIEUX , INC.LON2023-11-02
03573026636296VITEK® 2 AST-N812BIOMERIEUX , INC.LON2023-11-02
03573026636319VITEK® 2 AST-N813BIOMERIEUX , INC.LON2023-11-02
03573026636333VITEK® 2 AST-XN33BIOMERIEUX , INC.LON2023-11-02
03573026636128VITEK® 2 AST-N810BIOMERIEUX , INC.LON2023-11-01
00382904492823BD Phoenix™ NMIC/ID-308BECTON, DICKINSON AND COMPANYLON2023-10-24
00382904492830BD Phoenix™ NMIC-307BECTON, DICKINSON AND COMPANYLON2023-10-24
00382904492922BD Phoenix™ NMIC-306BECTON, DICKINSON AND COMPANYLON2023-10-24
00382904492946BD Phoenix™ NMIC-305BECTON, DICKINSON AND COMPANYLON2023-10-24