Eurotrol GlucoTrol-NG 170.003.002

GUDID 08718734960577

Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.

Eurotrol B.V.

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• Primary Device ID: 08718734960577
• NIH Device Record Key: d9525769-3f71-4c33-8280-c2be7d4b7589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eurotrol GlucoTrol-NG
• Version Model Number: GlucoTrol-NG Level 3
• Catalog Number: 170.003.002
• 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: 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	08718734960577 [Package]; Contains: 08718734960584; Package: Product Box [2 Units]; In Commercial Distribution
GS1	08718734960584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964053

FDA Product Code

• JJX: Single (Specified) Analyte Controls (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

On-Brand Devices [Eurotrol GlucoTrol-NG ]

• 08718734960591: Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verific
• 08718734960577: Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verific
• 08718734960560: Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verific