CueSee® Hyperbaric X-High 164.002.004

GUDID 08718734961109

CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas analyzers.

Eurotrol B.V.

Multiple blood gas analyte IVD, control

• Primary Device ID: 08718734961109
• NIH Device Record Key: 78e02d51-1e96-493b-a79d-d7a117cb66c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® Hyperbaric X-High
• Version Model Number: 164.002.004
• Catalog Number: 164.002.004
• 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: 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	08718734961093 [Primary]
GS1	08718734961109 [Package]; Contains: 08718734961093; Package: Product box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955340

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: 2021-06-16
• Device Publish Date: 2021-06-08

Devices Manufactured by Eurotrol B.V.

• 08718734962526 - CueSee VeriSTAT®: 2024-11-06 CueSee VeriSTAT® S1 is an unassayed quality control material for professional use to verify the performance characteristics of
• 08718734962618 - CueSee VeriSTAT®: 2024-11-06 CueSee VeriSTAT® S2 is an unassayed quality control material for professional use to verify the performance characteristics of
• 08718734962625 - CueSee VeriSTAT®: 2024-11-06 CueSee VeriSTAT® S3 is an unassayed quality control material for professional use to verify the performance characteristics of
• 08718734962632 - CueSee VeriSTAT®: 2024-11-06 CueSee VeriSTAT® LV is an unassayed quality control material for professional use to verify the performance characteristics of
• 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