| Primary Device ID | 00853799007541 |
| NIH Device Record Key | 946e13be-c0a9-4993-8fa0-55dbd4a8922e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tenzing 7 Delivery Catheter |
| Version Model Number | Gen 1 |
| Company DUNS | 067429673 |
| Company Name | ROUTE 92 MEDICAL |
| 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 |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com | |
| Phone | 650-350-9416 |
| Customerservice@r92m.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853799007541 [Primary] |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-24 |
| Device Publish Date | 2024-05-16 |
| 00853799007237 | Tenzing 7 Delivery Catheter |
| 00853799007541 | Tenzing 7 Delivery Catheter |
| 00853799007534 | Tenzing 7 Delivery Catheter; Contains Tenzing 7 Delivery Catheter (00853799007541) |