C&S Medium 2805-05-10_PACK

GUDID M44528050510PCK0

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.

MEDICAL CHEMICAL CORPORATION

Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD Carey-Blair transport medium IVD

• Primary Device ID: M44528050510PCK0
• NIH Device Record Key: eac4cd23-86f9-4a16-ae47-d8dd5117f8c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C&S Medium
• Version Model Number: 2805-05-10_PACK
• Catalog Number: 2805-05-10_PACK
• Company DUNS: 008496861
• Company Name: MEDICAL CHEMICAL CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M44528050510PCK0 [Unit of Use]
HIBCC	M44528050510PCK1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150887

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [C&S Medium]

• M445280505WB0: A modified Cary and Blair Medium intended to be used for the preservation and transport of gram
• M445280505REDSP02: A modified Cary and Blair Medium intended to be used for the preservation and transport of gram
• M445280505ORNG2: A modified Cary and Blair Medium intended to be used for the preservation and transport of gram
• M44528050510PCK0: A modified Cary and Blair Medium intended to be used for the preservation and transport of gram
• M4452805050: A modified Carey and Blair Medium intended to be used for the preservation and transport of gram