Eurotrol

GUDID 08718734960928

Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level. It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit .

Eurotrol B.V.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 08718734960928
• NIH Device Record Key: 887fe105-fcc2-49d2-88c0-690ee89f2a82
• Commercial Distribution Discontinuation: 2021-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Eurotrol
• Version Model Number: 183.000.005
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08718734960928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121468

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-09-12

On-Brand Devices [Eurotrol]

• 08718734960928: Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level. It is a c
• 08718734960904: 179.003.010
• 08718734960881: 179.002.010
• 08718734960867: 179.001.010
• 08718734960539: Assayed Quality control solution
• 08718734960515: Assayed Quality control solution
• 08718734960492: Assayed Quality control solution