HemoCue® Hb 201 DM Analyzer 121135

GUDID 07311091211354

HemoCue Hb 201 DM Analyzer g/dL

Hemocue AB

Haemoglobin analyser IVD, point-of-care

• Primary Device ID: 07311091211354
• NIH Device Record Key: a2bb5176-fbe7-4831-9212-d8b8d2462323
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® Hb 201 DM Analyzer
• Version Model Number: 121135
• Catalog Number: 121135
• Company DUNS: 356164426
• Company Name: Hemocue AB
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage in
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07311091211354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041234

FDA Product Code

• GKR: System, Hemoglobin, Automated

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-31

On-Brand Devices [HemoCue® Hb 201 DM Analyzer]

• 07311091211460: HemoCue Hb 201 DM Analyzer g/L
• 07311091211354: HemoCue Hb 201 DM Analyzer g/dL