Schaedler Blood Agar OxyPlate

Basic Information

• Brand Name: Schaedler Blood Agar OxyPlate
• Primary DI: 00850056467063
• Version / Model: O-SW-BA
• Catalog Number: O-SW-BA
• 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: f8277efd-875b-49b6-b27e-fb358afe199f

Device Description

Culture Media, Enriched

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: 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
KZI	CULTURE MEDIA, ENRICHED	Microbiology	866.2330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58688	Enriched agar culture medium IVD	An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850056467063	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