| Primary Device ID | B090A51352 |
| NIH Device Record Key | e1c3033b-8117-4695-aab4-8e3f4848bab3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aspire Max 5 Aspiration Catheter 135cm |
| Version Model Number | A5-135 |
| Catalog Number | A5-135 |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B090A51350 [Primary] |
| HIBCC | B090A51351 [Package] Contains: B090A51350 Package: Shelf Carton [1 Units] In Commercial Distribution |
| HIBCC | B090A51352 [Package] Contains: B090A51351 Package: Shipper [9 Units] In Commercial Distribution |
| DXE | Catheter, Embolectomy |
| QEZ | Aspiration Thrombectomy Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-12 |
| Device Publish Date | 2017-08-17 |
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