uTASWako i30

Basic Information

• Brand Name: uTASWako i30
• Primary DI: 00856626006229
• Version / Model: 991-60301
• Catalog Number: 991-60301
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Labeler DUNS: 690598875
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: e1c5d335-3d8f-42aa-9f57-c130f38b72bb
• Distribution End Date: 2020-10-23

Device Description

In-Vitro Diagnostic Use

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: No
• 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
OUE	Micro Total Analysis Instrument System	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57837	Electrophoresis analyser IVD	An electrically-powered automated or semi-automated laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856626006229	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100464	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius