WASPLab® Single Incubator

Basic Information

• Brand Name: WASPLab® Single Incubator
• Primary DI: 58050148211438
• Version / Model: W087-011
• Catalog Number: W087-011
• Company Name: COPAN WASP SRL
• Labeler DUNS: 434263590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-27
• Public Version: 1
• Public Version Date: 2021-05-05
• Public Version Status: New
• Public Device Record Key: e89773d2-ad98-4317-a1c9-72f9795798d5

Device Description

WASPLab® Single Incubator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	862.2100	1
JTQ	Bath, Incubators/Water, All	Microbiology	866.2540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63609	Microbial incubator/imaging system IVD	An electrically-powered device intended to provide ideal conditions for microbial growth with an incubator, and to capture digital images of the specimens contained within the incubator at specified time intervals. It consists of an incubator unit with multiple shelves, a camera and a display unit for microbial growth monitoring. The system automatically monitors and controls temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It may have an integrated robotic transfer arm for loading and unloading the incubator onto/from other instruments. The device may be a single unit or modular assembly.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	58050148211438	GS1

Customer Contacts

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