ASFA® SPOTTER

Basic Information

• Brand Name: ASFA® SPOTTER
• Primary DI: 08800066300111
• Version / Model: MBD-SP-ST006
• Company Name: MBD CO., Ltd.
• Labeler DUNS: 690430688
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-21
• Public Version: 1
• Public Version Date: 2023-11-29
• Public Version Status: New
• Public Device Record Key: 2999dc82-eef6-467a-aec4-85f36057a0d6

Device Description

ASFA SPOTTER: It is used to precisely and accurately dispense biological samples such as cells, drugs, and viruses into well plates and microchips.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	866.2500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61712	Microbial specimen inoculation/streaking/colony-picking instrument IVD	An electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800066300111	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	1045	Millimeter
Depth	600	Millimeter
Height	618	Millimeter

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius