PRAS Peptone Yeast Extract Broth w/ Lactate (PY LACTATE)

Basic Information

• Brand Name: PRAS Peptone Yeast Extract Broth w/ Lactate (PY LACTATE)
• Primary DI: 00810048902491
• Version / Model: AS-846
• Catalog Number: AS-846
• Company Name: ANAEROBE SYSTEMS
• Labeler DUNS: 021192653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-01-01
• Public Version: 1
• Public Version Date: 2022-01-10
• Public Version Status: New
• Public Device Record Key: ff43355d-ec2f-4d9a-ad59-5ac41f1593f0

Device Description

AS-846 Peptone Yeast Extract Broth with Lactate (PY LACTATE) is designed for the determination of lactate fermentation by anaerobic bacteria for identification. Pre-reduced anaerobically sterilized (PRAS). 10 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	00810048902484	GS1
Primary	00810048902491	GS1

Customer Contacts

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

Storage Conditions

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