CueSee® BGEM 345.000.005

GUDID 08718734963028

CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, glucose, lactate, urea and creatinine measurements on blood gas, electrolytes and metabolite analyzers. For laboratory and near-patient (point-of-care) testing by healthcare professionals. CueSee® BGEM 1|2|3|4|5 contains: 1x CueSee® BGEM 1 (DI: 08718734962946) 1x CueSee® BGEM 2 (DI: 08718734962953) 1x CueSee® BGEM 3 (DI: 08718734962960) 1x CueSee® BGEM 4 (DI: 08718734962977) 1x CueSee® BGEM 5 (DI: 08718734962984)

Eurotrol B.V.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 08718734963028
• NIH Device Record Key: a585fd83-affc-416c-93cf-6413c1e79cd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® BGEM
• Version Model Number: 1|2|3|4|5
• Catalog Number: 345.000.005
• 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: false
• 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	08718734963028 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls 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: 2025-08-04
• Device Publish Date: 2025-07-25

On-Brand Devices [CueSee® BGEM]

• 08718734963028: CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, p
• 08718734963011: CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, p
• 08718734963004: CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, p
• 08718734962991: CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, p