| Primary Device ID | 05099169405035 |
| NIH Device Record Key | 67f9af86-7c20-4e60-8b2e-aca55ad30f1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Model 4000 |
| Version Model Number | 4000 |
| Company DUNS | 219683489 |
| Company Name | VITALOGRAPH (IRELAND) LIMITED |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05099169405035 [Package] Contains: 15099169405032 Package: [1 Units] In Commercial Distribution |
| GS1 | 15099169405032 [Primary] |
| GS1 | 35099169405036 [Package] Package: [25 Units] In Commercial Distribution |
| BZG | SPIROMETER, DIAGNOSTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-08 |
| 05099169407978 | 4000 RESPIRATORY MONITOR LUNG MONITOR BT |
| 05099169407701 | 4000 RESPIRATORY MONITOR LUNG MONITOR BT (BASIC PACK) |
| 05099169407534 | 4000 RESPIRATORY MONITOR LUNG MON. BT GERMAN WITH REPORTS |
| 05099169407503 | 4000 RESPIRATORY MONITOR LUNG MONITOR BT INT |
| 35099169407498 | 4000 RESPIRATORY MONITOR LUNG MONITOR USB |
| 05099169407480 | 4000 RESPIRATORY MONITOR LUNG MONITOR USB (BASIC PACK) |
| 35099169407306 | 4000 RESP LUNG MONITOR USB - MED (BULK PACK) |
| 05099169407039 | 4000 RESPIRATORY MONITOR LUNG MON. USB GERMAN WITH REPORTS |
| 05099169407008 | 4000 RESPIRATORY MONITOR LUNG MONITOR USB INT. |
| 35099169405500 | 4000 RESPIRATORY MONITOR LUNG MONITOR |
| 05099169405035 | 4000 RESPIRATORY MONITOR LUNG AGE GERMAN |
| 35099169405012 | 4000 RESPIRATORY MONITOR LUNG AGE US |
| 05099169405004 | 4000 RESPIRATORY MONITOR LUNG AGE |
| 05099169404991 | 4000 RESPIRATORY MONITOR COPD-6 USB |
| 05099169404984 | 4000 RESPIRATORY MONITOR COPD-6 USB (BASIC PACK) |
| 05099169404601 | nmd-1 USB SANTHERA |
| 05099169404595 | 4000 RESPIRATORY MONITOR COPD-6 USB KOREAN |
| 05099169404533 | 4000 RESPIRATORY MONITOR COPD-6 USB GERMAN WITH REPORTS |
| 05099169404519 | 4000 RESPIRATORY MONITOR COPD-6 USB US |
| 05099169404502 | 4000 RESPIRATORY MONITOR COPD-6 USB INT. |
| 05099169404496 | 4000 RESPIRATORY MONITOR ASMA-1 |
| 35099169404480 | 4000 RESPIRATORY MONITOR ASMA-1 USB |
| 05099169404472 | 4000 RESPIRATORY MONITOR ASMA-1 USB (BASIC PACK) |
| 05099169404465 | 4000 RESPIRATORY MONITOR ASMA-1 USB STANDARD-ALL TESTS SAVED |
| 05099169404038 | 4000 RESPIRATORY MONITOR ASMA-1 USB GERMAN WITH REPORTS |
| 05099169404007 | 4000 RESPIRATORY MONITOR ASMA-1 USB INT. |
| 05099169403789 | 4000 RESPIRATORY MONITOR LUNG MONITOR BT IC (1) |
| 05099169403734 | MODEL 4000 RESP. MON. LUNG MONITOR BT SMART (BULK) |
| 05099169403727 | MODEL 4000 RESPIRATORY MONITOR LUNG MONITOR BT SMART INTL |
| 05099169403703 | 4000 RESPIRATORY MONITOR COPD-6 BT (BASIC PACK) |
| 05099169403642 | 4000 RESPIRATORY MONITOR COPD-6 BT KOREAN |
| 35099169403636 | 4000 RESPIRATORY MONITOR LUNG MONITOR BT - 2Net (BULK PACK) |
| 35099169403629 | 4000 RESPIRATORY MONITOR COPD-6 BT - 2Net (BULK PACK) |
| 05099169403611 | 4000 RESPIRATORY MONITOR ASMA-1 BT - 2Net (BULK PACK) |
| 05099169403604 | 4000 RESPIRATORY MONITOR ASMA-1 BT (1) |
| 05099169403598 | 4000 RESPIRATORY MONITOR LUNG MONITOR BT - 2NET |
| 05099169403581 | 4000 RESPIRATORY MONITOR COPD-6 BT - 2NET |
| 05099169403574 | 4000 RESPIRATORY MONITOR ASMA-1 BT - 2NET |
| 05099169403550 | 4000 RESPIRATORY MONITOR ASMA-1 BT GERMAN |
| 05099169403543 | 4000 RESPIRATORY MONITOR ASMA-1 BT GERMAN - HEALTH INSIGHT |
| 05099169403536 | 4000 RESPIRATORY MONITOR COPD-6 BT GERMAN WITH REPORTS |
| 05099169403505 | 4000 RESPIRATORY MONITOR COPD-6 BT INT |
| 05099169403482 | 4000 RESPIRATORY MONITOR ASMA-1 BT (1) |
| 35099169403476 | 4000 RESPIRATORY MONITOR ASMA-1 BT (1) |
| 35099169403469 | 4000 RESPIRATORY MONITOR ASMA-1 BT (1) |
| 05099169403208 | 4000 RESPIRATORY MONITOR ASMA-1 BT (BASIC PACK) |
| 05099169403031 | 4000 RESPIRATORY MONITOR ASMA-1 BT GERMAN WITH REPORTS |
| 05099169403000 | 4000 RESPIRATORY MONITOR ASMA-1 BT INT |
| 35099169402912 | 4000 RESPIRATORY MONITOR COPD-6 |
| 35099169402905 | 4000 RESPIRATORY MONITOR RC CHECK COPD-6 |