FDA.reportPublic FDA data

C&S Medium

Primary DI
M44528050510PCK0
Brand
C&S Medium
Company
MEDICAL CHEMICAL CORPORATION
Model
2805-05-10_PACK
Catalog number
2805-05-10_PACK
Device description
A modified Cary and Blair Medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150887000Para-Fix C&S MediumMedical Chemical Corporation2015-05-29JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M44528050510PCK1PrimaryHIBCC0
M44528050510PCK0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carey-Blair transport medium IVDA vessel containing transport medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008496861
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M445890151O&P Collection Vials C&S/Clean Kits890-15890-152020-08-31
M445891051O&P Collection Vials SAF / Clean/ C&S Kits891-05891-052020-08-31
M445891101Unifix / Clean / C&S Kits O&P Collection Vials891-10891-102020-08-31
M445891171Total-Fix / C&S / Clean O&P Collection Kits891-17891-172020-08-31
M44589117ORNGE1Total-Fix / C&S / Clean O&P Collection Kits891-17_ORNGE891-17_ORNGE2020-08-31
M445891201Formalin / C&S / Clean Stool Collection Kits891-20891-202020-08-31
M445892021Total-Fix / Formalin / C&S / Clean O&P Collection Kits892-02892-022020-08-31
M445892031Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M445892030Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M4454505K1Bone Marrow Kit4505K4505K2020-09-09
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit891-08891-082020-08-31
M445693A50PACK1SED-CONNECT693A 50 PACK693A 50 PACK2016-09-20
M445693AESEDEA50PACK1SED-CONNECT693A-E SED+EA693A-E SED+EA2016-09-20
M445693AFUNNEL1SED-CONNECT693A-FUNNEL693A-FUNNEL2016-09-20
M445693ASAMPLE1SED-CONNECT693A-Sample693A-Sample2016-09-20
M445694A1MICRO-SED694A694A2016-09-20
M445694AEA1MICRO-SED694A-EA694A-EA2016-09-20
M445694ASAMPLE1MICRO-SED694A-Sample694A-Sample2016-09-20
M445694ATUBEFUNNEL1MICRO-SED694A-TUBE/FUNNEL 1000694A-TUBE/FUNNEL 10002016-09-20
M445695A1PARA-SED695A695A2016-09-20

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Primary DI, Brand, Company table
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