BD BBL™ Sensi-Disc™ Imipenem 10 µg

Primary DI
30382902316450
Brand
BD BBL™ Sensi-Disc™ Imipenem 10 µg
Company
BECTON, DICKINSON AND COMPANY
Model
231645
Catalog number
231645
Device description
BD BBL™ Sensi-Disc™ Imipenem 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
JTTSUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTTSusceptibility Test Powders, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K855106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K855106000IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645Bd Becton Dickinson Vacutainer Systems Preanalytic1986-03-06JTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902316450PrimaryGS10
00382902316459Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290231645030382902316450
00382902316459003829023164593829023164590382902316459

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
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382902316442BD BBL™ Sensi-Disc™ Imipenem 10 µgBECTON, DICKINSON AND COMPANYJTT2016-05-03