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

• 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.

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• 08718734962625 - CueSee VeriSTAT®: 2024-11-06 CueSee VeriSTAT® S3 is an unassayed quality control material for professional use to verify the performance characteristics of
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• 08718734960973 - HemoTrol WB: 2024-08-29 HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoC
• 08718734960959 - HemoTrol WB: 2024-08-29 HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoC
• 08718734960966 - HemoTrol WB: 2024-08-29 HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoC
• 08718734960867 - Eurotrol: 2022-09-16