CueSee® CO-OX AN01486A01

GUDID 08718734961000

CueSee® CO-OX S1A is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Eurotrol B.V.

Multiple haemoglobin subtype IVD, control

• Primary Device ID: 08718734961000
• NIH Device Record Key: 94c41f1b-b094-463c-9b70-a934d5961542
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® CO-OX
• Version Model Number: S1A
• Catalog Number: AN01486A01
• Company DUNS: 412925992
• Company Name: Eurotrol B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	08718734961000 [Primary]
GS1	08718734961055 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• GGM: Control, Hemoglobin

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: 2021-12-27
• Device Publish Date: 2021-12-19

On-Brand Devices [CueSee® CO-OX]

• 08718734961635: CueSee® CO-OX LVB is an unassayed material for professional use containing total hemoglobin (tH
• 08718734961628: CueSee® CO-OX S5B is an unassayed material for professional use containing total hemoglobin (tH
• 08718734962403: CueSee® CO-OX S4B is an unassayed material for professional use containing total hemoglobin (tH
• 08718734961611: CueSee® CO-OX S3B is an unassayed material for professional use containing total hemoglobin (tH
• 08718734962397: CueSee® CO-OX S2B is an unassayed material for professional use containing total hemoglobin (tH
• 08718734961604: CueSee® CO-OX S1B is an unassayed material for professional use containing total hemoglobin (tH
• 08718734961086: CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the per
• 08718734961079: CueSee® CO-OX S5A is an assayed quality control material for professional use to verify the per
• 08718734961062: CueSee® CO-OX S3A is an assayed quality control material for professional use to verify the per
• 08718734961000: CueSee® CO-OX S1A is an assayed quality control material for professional use to verify the per
• 08718734962656: CueSee® CO-OX S6B is an unassayed material for professional use containing total hemoglobin (tH