OxyPRAS Plus BBE/KVL Bi-Plate

Basic Information

• Brand Name: OxyPRAS Plus BBE/KVL Bi-Plate
• Primary DI: 00850056467025
• Version / Model: B-BCD-KV
• Catalog Number: B-BCD-KV
• Company Name: Oxyrase, Inc.
• Labeler DUNS: 157281882
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-30
• Public Version: 1
• Public Version Date: 2023-12-08
• Public Version Status: New
• Public Device Record Key: d2882a6a-6ebc-4d03-993d-1089052ab0e3

Device Description

Culture Media, Selective and Non-Differential

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSJ	CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL	Microbiology	866.2360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850056467025	GS1

Customer Contacts

• Phone: [phone] ext. 233
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	24	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius