| Primary Device ID | EBUHBKCALCONSET0 |
| NIH Device Record Key | a1bcbfe9-454f-4282-bec9-a7268c908319 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BÜHLMANN fCAL® turbo Control Kit |
| Version Model Number | B-KCAL-CONSET |
| Company DUNS | 481261006 |
| Company Name | Bühlmann Laboratories AG |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBUHBKCALCONSET0 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2019-11-01 |
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| 04260714340007 - fCAL turbo | 2022-06-21 |
| 07613336169926 - fCAL turbo | 2022-06-10 |
| EBUH089104991900 - fCAL Calibrator Set | 2022-06-10 |
| EBUH089109870010 - CALEX Cap | 2021-07-22 |
| EBUHBIPOCTRABS0 - Quantum Blue® Reader | 2021-01-20 |
| EBUHBKPELACONSET0 - BÜHLMANN fPELA® turbo Control Kit | 2020-06-30 |