| Primary Device ID | 06420099001087 |
| NIH Device Record Key | 077ba55d-9bc3-41a4-8371-fd87b7ff870d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M915-PCD, PCD Spirometer Kit |
| Version Model Number | M9488-PCD |
| Company DUNS | 369263660 |
| Company Name | Medikro Oy |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06420099001087 [Package] Contains: 06420099001094 Package: [1 Units] In Commercial Distribution |
| GS1 | 06420099001094 [Primary] |
| BZG | Spirometer, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-09 |
| Device Publish Date | 2019-11-29 |
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| 06420099001087 - M915-PCD, PCD Spirometer Kit | 2019-12-09 |
| 06420099001087 - M915-PCD, PCD Spirometer Kit | 2019-12-09 |
| 06420099001124 - M9264-PCD-200, Pressure Tube | 2019-12-09 |
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| 06420099000486 - M9264-200, Pressure Tube | 2018-08-13 |
| 06420099000677 - M9227, Nose Clip | 2018-08-13 |