CueSee® Hypoxic 166.001.005

GUDID 08718734960669

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).

Eurotrol B.V.

Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control Multiple blood gas analyte IVD, control

• Primary Device ID: 08718734960669
• NIH Device Record Key: 900ddfd9-46bd-4857-9b0e-2777943e68d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® Hypoxic
• Version Model Number: CueSee® Hypoxic X-Low
• Catalog Number: 166.001.005
• Company DUNS: 412925992
• Company Name: Eurotrol B.V.
• 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: false
• 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	08718734960652 [Primary]
GS1	08718734960669 [Package]; Contains: 08718734960652; Package: Product Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152553

FDA Product Code

• JJS: Controls For Blood-Gases, (Assayed And Unassayed)

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: 2020-10-16
• Device Publish Date: 2020-10-08

Devices Manufactured by Eurotrol B.V.

• 08718734960867 - Eurotrol: 2022-09-16
• 08718734960881 - Eurotrol: 2022-09-16
• 08718734960904 - Eurotrol: 2022-09-16
• 08718734960928 - Eurotrol: 2022-09-16 Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level. It is a convenience kit for the purposes
• 08718734961000 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX S1A is an assayed quality control material for professional use to verify the performance characteristics of the
• 08718734961062 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX S3A is an assayed quality control material for professional use to verify the performance characteristics of the
• 08718734961079 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX S5A is an assayed quality control material for professional use to verify the performance characteristics of the
• 08718734961086 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the performance characteristics of the