PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 FA/GLC (PYG TWEEN FA/GLC)

Basic Information

• Brand Name: PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 FA/GLC (PYG TWEEN FA/GLC)
• Primary DI: 00810048900763
• Version / Model: AS-825
• Catalog Number: AS-825
• Company Name: ANAEROBE SYSTEMS
• Labeler DUNS: 021192653
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-01
• Public Version: 3
• Public Version Date: 2021-12-31
• Public Version Status: Update
• Public Device Record Key: b481d1ed-4163-4eef-9959-f9c8f841889b
• Distribution End Date: 2021-12-31

Device Description

AS-825 Peptone Yeast Extract Broth with Glucose and Tween 80 FA/GLC (PYG TWEEN FA/GLC) is designed for the determination of glucose fermentation and Tween 80 stimulation by anaerobic bacteria for identification. PYG FA/GLC is recommended for use in identifying gram-positive bacteria within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 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
JSC	Culture Media, General Nutrient Broth	Microbiology	866.2350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58586	Basic/simple nutrient broth culture medium IVD	A non-selective, non-differential nutrient broth culture medium intended to be used to 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	00810048901975	GS1
Primary	00810048900763	GS1

Customer Contacts

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

Storage Conditions

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