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
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00382904003821BD Whitacre Spinal4003824003822023-09-02
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30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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