FDA.reportPublic FDA data

BD BBL™ Sensi-Disc™ Piperacillin/Tazobactam 100/10 µg

Primary DI
00382902316916
Brand
BD BBL™ Sensi-Disc™ Piperacillin/Tazobactam 100/10 µg
Company
BECTON, DICKINSON AND COMPANY
Model
231691
Catalog number
231691
Device description
BD BBL™ Sensi-Disc™ Piperacillin/Tazobactam 100/10 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
K940359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940359000PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISCBecton Dickinson Microbiology Systems1994-03-01JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902316916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902316916003829023169163829023169160382902316916

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

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00885403523536HemoSphere AltaHEMAPSC200HEMAPSC2002026-09-18
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKBB64EKBB2026-09-18
00885403533146TruWave Reusable Cable64EKGE164EKGE12026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKGE264EKGE22026-09-18
00885403533160TruWave Reusable Cable64EKH64EKH2026-09-18
00885403533610TruWave Reusable Cable70ANHS70ANHS2026-09-18
00885403533634Pressure Slave Cable70ANS70ANS2026-09-18
00885403533641Cable COO Catheter Interface70CC270CC22026-09-18
00885403533665TruWave Reusable CablePX15S162PX15S1622026-09-18
00885403533764Smart Pressure ControllerPC1QPC1Q2026-09-18
00885403533771Smart Pressure Controller Accessory KitPC1QAKPC1QAK2026-09-18
00885403543282TruWave Reusable CablePX12S162PX12S1622026-09-18
00885403543299TruWavePX17S162PX17S1622026-09-18
00885403543305TruWavePX21S162PX21S1622026-09-18
00885403543312TruWavePX6D162PX6D1622026-09-18
00885403543428TruWavePX6T162PX6T1622026-09-18
00885403543435TruWavePX2D162PX2D1622026-09-18
00885403543459TruWavePX11T162PX11T1622026-09-18
00885403543466TruWavePX7D162PX7D1622026-09-18

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