BD BBL™ Haemophilus Test Medium Agar (HTM Agar)

Primary DI
30382902219546
Brand
BD BBL™ Haemophilus Test Medium Agar (HTM Agar)
Company
BECTON, DICKINSON AND COMPANY
Model
221954
Catalog number
221954
Device description
Plate Haemophilus Test Medium Agar 8 Ea
Published
2016-12-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSOCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton AgarMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894216000HAEMOPHILUS TEST MEDIUM (HTM)AGARBd Becton Dickinson Vacutainer Systems Preanalytic1989-12-13JSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902219546PackageGS12Not in Commercial Distribution
10382902219542PrimaryGS10
00382902219545Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290221954630382902219546
1038290221954210382902219542
00382902219545003829022195453829022195450382902219545

GMDN Terms#

Term, Definition table
TermDefinition
Haemophilus species antimicrobial susceptibility culture medium IVDA supplemented culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on Haemophilus species isolated from a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth15Millimeter
Outer Diameter150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 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
4
DM exempt
false
Premarket exempt
false
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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00885403523253FOGARTY SOFTJAWSOFT33SOFT332026-07-30
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