OPTI CCA E-Glu Cassette BP7564

GUDID 00894472000275

OPTI CCA E-Glu Cassette

OPTI MEDICAL SYSTEMS, INC.

Multiple clinical chemistry enzyme IVD, reagent Multiple clinical chemistry enzyme IVD, reagent Multiple clinical chemistry enzyme IVD, reagent Multiple clinical chemistry enzyme IVD, reagent Multiple clinical chemistry enzyme IVD, reagent Multiple clinical chemistry enzyme IVD, reagent Multiple clinical chemistry enzyme IVD, reagent Multiple clinical chemistry enzyme IVD, reagent

• Primary Device ID: 00894472000275
• NIH Device Record Key: 771fe4a7-1beb-47af-81a8-058038caf8a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTI CCA E-Glu Cassette
• Version Model Number: 1
• Catalog Number: BP7564
• 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	00894472000275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131126

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2022-12-08
• Device Publish Date: 2019-09-03

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: 2022-12-08OPTI CCA E-Glu 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: 2020-12-21 OPTI Check Plus Tri-level controls