FDA.report

BD BBL™ Sensi-Disc™ Erythromycin - 15 µg

Primary DI
30382902312902
Brand
BD BBL™ Sensi-Disc™ Erythromycin - 15 µg
Company
BECTON, DICKINSON AND COMPANY
Model
231290
Catalog number
231290
Device description
BD BBL™ Sensi-Disc™ Erythromycin - 15 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JTNSUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Product Code Classifications

CodeDeviceSpecialtyClass
JTNSusceptibility Test Discs, AntimicrobialMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30382902312902PrimaryGS10
00382902312901Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290231290230382902312902
00382902312901003829023129013829023129010382902312901

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags

DUNS number
122561087
Device count
10
DM exempt
false
Premarket exempt
true
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

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