| Primary Device ID | 06972130470401 |
| NIH Device Record Key | 76053c6a-afd7-4419-8946-d21083e27fb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AWI |
| Version Model Number | 209-00-47 |
| Company DUNS | 554507451 |
| Company Name | Apex (Suzhou) Medical Products Company |
| Device Count | 120 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972130470401 [Unit of Use] |
| GS1 | 16972130470408 [Primary] |
| GS1 | 26972130470405 [Primary] |
| FQH | Lavage, Jet |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-04 |
| Device Publish Date | 2020-10-27 |
| 26972130470436 | Disposable Pulse Irrigation Kit |
| 06972130470418 | Hydra Adaptor |
| 06972130470401 | Tunnel Tip |
| 06972130470395 | Disposable Irrigation Bag(Apply to Trunk-L) |
| 06972130470388 | Disposable Irrigation Bag(Apply to Extremity) |
| 16972130470439 | Disposable Pulse Irrigation Kit |
| 16972130470422 | Standard Tip |
| 06972130470432 | Disposable Pulse Irrigation Kit |
| 06972130470425 | Standard Tip |
| 26972130470511 | Disposable Pulse Irrigation Kit |
| 06972130470517 | Disposable Pulse Irrigation Kit |
| 06972130470500 | Standard Tip |
| 16972130470507 | Standard Tip |
| 16972130470491 | Hydra Adaptor |
| 16972130470484 | Tunnel Tip |
| 16972130470477 | Disposable Irrigation Bag(Apply to Trunk-L) |
| 16972130470460 | Disposable Irrigation Bag(Apply to Extremity) |
| 16972130470514 | Disposable Pulse Irrigation Kit |
| 26972130470535 | Disposable Pulse Irrigation Kit |
| 16972130470538 | Disposable Pulse Irrigation Kit |
| 06972130470531 | Disposable Pulse Irrigation Kit |