HemoCue® Hb 301 Microcuvettes 111807
GUDID 07311091118073
HemoCue Hb 301 Microcuvettes 4x75 vial
Hemocue AB
Haemoglobin analyser IVD, point-of-care| Primary Device ID | 07311091118073 |
| NIH Device Record Key | 6b38d96a-5df6-4ab8-94bd-462bee7e2716 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemoCue® Hb 301 Microcuvettes |
| Version Model Number | 111807 |
| Catalog Number | 111807 |
| Company DUNS | 356164426 |
| Company Name | Hemocue AB |
| Device Count | 75 |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07311091118073 [Package] Contains: 17311091118070 Package: package [4 Units] In Commercial Distribution |
| GS1 | 17311091118070 [Primary] |
| GS1 | 27311091118077 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- BK060048
- Premarket Notification: K201217
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 | 2016-12-01 |
On-Brand Devices [HemoCue® Hb 301 Microcuvettes]
| 07311091118073 | HemoCue Hb 301 Microcuvettes 4x75 vial |
| 07311091118011 | HemoCue Hb 301 Microcuvettes 4x50 vial |
| 07311091118097 | HemoCue Hb 301 Microcuvettes 4x50 vial |
| 27311091118121 | HemoCue Hb 301 Microcuvettes 4x50 vial |
| 27311091118077 | HemoCue Hb 301 Microcuvettes 4x75 vial |
Trademark Results [HemoCue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOCUE 77756134 3912761 Live/Registered |
HemoCue AB 2009-06-10 |
 HEMOCUE 73352049 1222479 Dead/Cancelled |
Aktiebolaget Leo 1982-02-26 |
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