FDA.reportPublic FDA data

BD BBL™ Sensi-Disc™ Cefotaxime 30 µg

Primary DI
00382902316060
Brand
BD BBL™ Sensi-Disc™ Cefotaxime 30 µg
Company
BECTON, DICKINSON AND COMPANY
Model
231606
Catalog number
231606
Device description
BD BBL™ Sensi-Disc™ Cefotaxime 30 µg
Published
2016-05-03
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
JTNSUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTNSusceptibility Test Discs, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810564000CEFOTAXIME 30 MCG. SENSI-DISC.Bd Becton Dickinson Vacutainer Systems Preanalytic1981-03-31JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902316060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902316060003829023160603829023160600382902316060

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antibacterial susceptibility profile kit IVDA collection of reagents and other associated materials containing a range of antimicrobial agents that may be impregnated on individual testing discs, or in a strip format, intended to be used to determine the antibacterial susceptibility profile of a specific bacterial microorganism, in a clinical specimen and/or culture isolate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10OXOID LIMITEDJTN2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50OXOID LIMITEDJTN2025-12-12
00816576027194HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027200HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027088HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027057HardyDisk™HARDY DIAGNOSTICSJTN2025-07-18
00816576027071HardyDisk™HARDY DIAGNOSTICSJTN2025-07-14
00816576026975HardyDisk™HARDY DIAGNOSTICSJTN2025-07-14
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiOXOID LIMITEDJTN2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiOXOID LIMITEDJTN2024-10-28
05032384526123Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-01
05032384088423Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-07-05
05032384574964Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-07-05
00819398020732HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398020923HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398020725HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398021197HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00819398021548HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00819398021180HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00382902322559BD BBL™ Sensi-Disc™ Cefiderocol 30 µgBECTON, DICKINSON AND COMPANYJTN2023-06-16
05032384526116NAOXOID LIMITEDJTN2021-12-07
00816576028283HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00816576028306HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00816576028290HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00819398028103HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
00819398028110HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
00819398028097HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
05032384140480Oxoid™ Moxifloxacin Antimicrobial Susceptibility DisksOXOID LIMITEDJTN2020-01-30