PRAS Dilution Blanks

Basic Information

• Brand Name: PRAS Dilution Blanks
• Primary DI: 00810048901234
• Version / Model: AS-918-500
• Catalog Number: AS-918-500
• Company Name: ANAEROBE SYSTEMS
• Labeler DUNS: 021192653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: 374e99f5-9295-4003-a5fc-0f85c1d0bc4a

Device Description

AS-918-500 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent colorless liquid. 1 bottle 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
JSC	Culture Media, General Nutrient Broth	Microbiology	866.2350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810048901234	GS1

Customer Contacts

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

Storage Conditions

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