| Primary Device ID | 15060120952650 |
| NIH Device Record Key | c47c9ea2-bb3f-482a-888d-6316dcb0b2c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ECO HME |
| Version Model Number | 9080/750 Resmed 27922 Rev01 |
| Company DUNS | 420798347 |
| Company Name | GVS Technology (Suzhou) Co., Ltd. |
| Device Count | 50 |
| 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 | 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 Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060120952650 [Primary] |
| GS1 | 15060120952653 [Unit of Use] |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| 40080196149781 - 4244/M/711BRSA059/0001 | 2020-09-22 62.002.0099.4244/M/711BRSA |
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| 35019315082973 - ECO Range - Phase 1 | 2018-07-06 |
| 35019315082997 - ECO Range - Mini Series | 2018-07-06 |
| 35019315083031 - 9080/750BRSA074/0001 | 2018-07-06 |
| 35019315083208 - ECO Maxi Pleat - Pleated HEPA Filter | 2018-07-06 |
| 35019315083215 - ECO Range - Maxi Series | 2018-07-06 |
| 35019315083291 - ECO Range - Maxi Series | 2018-07-06 |