PRAS Brucella Agar Deep 18mL (BRU DEEP 18mL)

Basic Information

• Brand Name: PRAS Brucella Agar Deep 18mL (BRU DEEP 18mL)
• Primary DI: 00810048901395
• Version / Model: AS-810
• Catalog Number: AS-810
• Company Name: ANAEROBE SYSTEMS
• Labeler DUNS: 021192653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-01
• Public Version: 1
• Public Version Date: 2020-05-11
• Public Version Status: New
• Public Device Record Key: bf3b40b2-2a5c-41ee-ac8e-89df2dded2a9

Device Description

AS-810 Brucella Agar Deep 18 mL (BRU DEEP 18mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 18 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes per pack.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	866.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810048901890	GS1
Primary	00810048901395	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius