OPTI Check Plus HC7009

GUDID 00894472000114

OPTI Check Plus Tri-level controls

OPTI MEDICAL SYSTEMS, INC.

Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 00894472000114
• NIH Device Record Key: 28ba651f-cfcd-4053-b84f-fbd836bd73c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTI Check Plus
• Version Model Number: 1
• Catalog Number: HC7009
• Company DUNS: 801458279
• Company Name: OPTI MEDICAL SYSTEMS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894472000114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001632

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-21
• Device Publish Date: 2019-08-06

Devices Manufactured by OPTI MEDICAL SYSTEMS, INC.

• 00894472000237 - B Cassette: 2022-12-08 B Cassette Carton
• 00894472000244 - OPTI CCA E Cassette: 2022-12-08 OPTI CCA E Cassette
• 00894472000251 - E-Ca Cassette Carton: 2022-12-08 E-Ca Cassette
• 00894472000268 - OPTI CCA E-Cl Cassette: 2022-12-08 OPTI CCA E-Cl Cassette
• 00894472000275 - OPTI CCA E-Glu Cassette: 2022-12-08 OPTI CCA E-Glu Cassette
• 00894472000107 - OPTI Check Control Tri Level: 2020-12-21 OPTI Check Controls Tri Level
• 00894472000114 - OPTI Check Plus: 2020-12-21OPTI Check Plus Tri-level controls
• 00894472000114 - OPTI Check Plus: 2020-12-21 OPTI Check Plus Tri-level controls