| Primary Device ID | 00616258003856 |
| NIH Device Record Key | beea8b49-5cc2-45b8-a7e0-fb2c54f17417 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPIROFLEX VG |
| Version Model Number | 106608-001 |
| Catalog Number | 106608 |
| Company DUNS | 079415074 |
| Company Name | Bayer Healthcare LLC |
| 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 | true |
| 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 |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com | |
| Phone | 763-780-4555 |
| michael.burnside@bayer.com |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616258003856 [Primary] |
| DXE | Catheter, Embolectomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-10-07 |
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