HemoCue® 801 Connect 139168

GUDID 07311091391681

HemoCue® 801 Connect

Hemocue AB

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 07311091391681
• NIH Device Record Key: 02ad6600-8af0-4a6b-ab7e-00af877062f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® 801 Connect
• Version Model Number: 139168
• Catalog Number: 139168
• Company DUNS: 356164426
• Company Name: Hemocue AB
• 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: false
• Expiration Date: false
• 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	07311091391681 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-04-25

Devices Manufactured by Hemocue AB

• 27311091118077 - HemoCue® Hb 301 Microcuvettes: 2022-11-07 HemoCue Hb 301 Microcuvettes 4x75 vial
• 27311091118121 - HemoCue® Hb 301 Microcuvettes: 2022-09-07 HemoCue Hb 301 Microcuvettes 4x50 vial
• 07311091218278 - HemoCue® Hb301 Analyzer: 2020-09-14 HemoCue Hb301 Analyzer g/dL
• 07311091118097 - HemoCue® Hb 301 Microcuvettes: 2020-09-14 HemoCue Hb 301 Microcuvettes 4x50 vial
• 07311091391681 - HemoCue® 801 Connect: 2019-07-02HemoCue® 801 Connect
• 07311091391681 - HemoCue® 801 Connect: 2019-07-02 HemoCue® 801 Connect
• 07311091206237 - HemoCue® Albumin 201 Analyzer: 2019-05-03 HemoCue Albumin 201 Analyzer mg/L
• 17311091106084 - HemoCue® Urine Albumin Microcuvettes: 2019-05-03 HemoCue Urine Albumin Microcuvettes 2x25 single
• 17311091119022 - HemoCue® Hb 801 Microcuvettes: 2019-03-11 HemoCue Hb 801 Microcuvettes 4x50 vial