| Primary Device ID | 07350040790250 |
| NIH Device Record Key | 3cf68b45-5c5f-4e2d-9bde-fdb6f3593d43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro pipette, plastic EDTA |
| Version Model Number | Micro pipette, plastic EDTA 1x100 |
| Catalog Number | 1070039 |
| Company DUNS | 354417933 |
| Company Name | Boule Medical 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 | true |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 07350040790250 - Micro pipette, plastic EDTA | 2024-10-14Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers. |
| 07350040790250 - Micro pipette, plastic EDTA | 2024-10-14 Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection |
| 07350040791417 - Boule EasyCleaner | 2024-10-14 Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic sys |
| 07350040796399 - Medonic M51-D Diluent | 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51.
The diluent dilutes the blood sample to en |
| 07350040796405 - Medonic M51-L1 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51.
The lyse reagents lyses the red blood cell |
| 07350040796412 - Medonic M51-L2 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51.
The lyse reagents lyses the red blood cell |
| 07350040796429 - Swelab Lumi-D Diluent | 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi.
The diluent dilutes the blood sample to en |
| 07350040796436 - Swelab Lumi-L1 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer.
The lyse reagents lyses the red b |
| 07350040796443 - Swelab Lumi-L2 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer.
The lyse reagents lyses the red b |