CueSee® CO-OX AN01718A01

GUDID 08718734961604

CueSee® CO-OX S1B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions 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 Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control Multiple haemoglobin subtype IVD, control

• Primary Device ID: 08718734961604
• NIH Device Record Key: 5299a839-beae-4c15-a089-7a88cf57fb05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® CO-OX
• Version Model Number: S1B
• Catalog Number: AN01718A01
• 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	08718734961550 [Primary]
GS1	08718734961604 [Package]; Contains: 08718734961550; 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