SelectaLyte (Sodium Electrode)

GUDID 00850229007324

AWARENESS TECHNOLOGY, INCORPORATED

Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

• Primary Device ID: 00850229007324
• NIH Device Record Key: c6a3eabe-aa7e-4e63-9a7e-8eb0ffe8c6fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SelectaLyte (Sodium Electrode)
• Version Model Number: 3910
• Company DUNS: 071065130
• Company Name: AWARENESS TECHNOLOGY, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850229007324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171476

FDA Product Code

• JGS: Electrode, Ion Specific, Sodium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-04
• Device Publish Date: 2019-06-26

Devices Manufactured by AWARENESS TECHNOLOGY, INCORPORATED

• 00850229007010 - StatFax: 2023-06-13
• 00850229007027 - StatFax: 2023-06-13
• 00850229007034 - StatFax: 2023-06-13
• 00850229007041 - StatFax: 2023-06-13
• 00850229007072 - StatFax: 2023-06-13 Digital Dry Bath
• 00850229007089 - StatFax: 2023-06-13 Digital Dry Bath
• 00850229007102 - StatFax: 2023-06-13
• 00850229007126 - LumiStat: 2023-06-13