Mast Assure

Basic Information

• Brand Name: Mast Assure
• Primary DI: 15060392376529
• Version / Model: M11004
• Catalog Number: M11004
• Company Name: MAST GROUP LIMITED
• Labeler DUNS: 212623821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-25
• Public Version: 1
• Public Version Date: 2018-08-27
• Public Version Status: New
• Public Device Record Key: 45eb93d6-7aee-416e-8fb6-745be735ed07

Device Description

Vibrio cholerae Monovalent Antiserum - OGAWA - 2ml

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
GSQ	Antiserum, Vibrio Cholerae, All Varieties	Microbiology	866.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51842	Vibrio cholerae antigen (multiple serotype) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serotypes of Vibrio cholerae bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060392376529	GS1

Storage Conditions

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