NATCH S-F11B System

Basic Information

• Brand Name: NATCH S-F11B System
• Primary DI: 06955792714359
• Version / Model: S-F11B (US)
• Company Name: Sansure Biotech Inc.
• Labeler DUNS: 421167832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-15
• Public Version: 1
• Public Version Date: 2023-06-23
• Public Version Status: New
• Public Device Record Key: a5d8460b-ff70-40ae-9e7b-d2680fdf7da7

Device Description

The NATCH S-F11B System is intended for extracting and purifying nucleic acids from human samples. Instrument should be used by trained operators in clinical laboratories processing samples for molecular testing.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JJH	Clinical Sample Concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60736	Nucleic acid sample preparation instrument IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06955792714359	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity