CueSee® Hyperbaric 350.001.005

GUDID 08718734963042

CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas analyzers at the upper limit of the measuring range. For laboratory and near patient (point-of-care) testing by healthcare professionals.

Eurotrol B.V.

Multiple blood gas analyte IVD, control

• Primary Device ID: 08718734963042
• NIH Device Record Key: 73be1b32-b334-4da8-9cbd-5633c57834ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® Hyperbaric
• Version Model Number: 1
• Catalog Number: 350.001.005
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	08718734963035 [Primary]
GS1	08718734963042 [Package]; Contains: 08718734963035; Package: Box [5 Units]; In Commercial Distribution

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: 2026-01-15
• Device Publish Date: 2026-01-07

Devices Manufactured by Eurotrol B.V.

• 08718734963042 - CueSee® Hyperbaric: 2026-01-15CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas analyzers at the upper limit of the measuring range. For laboratory and near patient (point-of-care) testing by healthcare professionals.
• 08718734963042 - CueSee® Hyperbaric: 2026-01-15 CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas a
• 08718734962991 - CueSee® BGEM: 2025-08-04 CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, gl
• 08718734963004 - CueSee® BGEM: 2025-08-04 CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, gl
• 08718734963011 - CueSee® BGEM: 2025-08-04 CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, gl
• 08718734963028 - CueSee® BGEM: 2025-08-04 CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, gl
• 08718734962779 - CueSee® Coag: 2025-04-16 CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International
• 08718734962786 - CueSee® Coag: 2025-04-16 CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International
• 08718734962793 - CueSee® Coag: 2025-04-16 CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International