| Primary Device ID | 00853799007688 |
| NIH Device Record Key | a377245c-a1e6-414d-a15b-0ed00042375d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5 |
| Version Model Number | Gen 1 |
| Catalog Number | REF 7001-54-148R |
| 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 | true |
| 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 |
|---|---|
| GS1 | 00853799007688 [Primary] |
| NRY | Catheter, Thrombus Retriever |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-07 |
| Device Publish Date | 2024-05-30 |
| 00853799007978 - Tenzing 7 Delivery Catheter, Single Pack | 2025-08-05 Tenzing 7 Delivery Catheter - Single Pack; Contains Tenzing 7 Delivery Catheter (00853799007541) |
| 00853799007985 - Tenzing 7 Delivery Catheter, 2-pack | 2025-08-05 Tenzing 7 Delivery Catheter, 2-pack; Contains 2x of Tenzing 7 Delivery Catheter (00853799007541) |
| 00853799007701 - 8F Base Camp system 2.0 80cm | 2024-10-22 8F Base Camp system 2.0 80cm |
| 00853799007718 - 8F Base Camp system 2.0 80cm | 2024-10-22 8F Base Camp system 2.0 80cm; Contains 8F Base Camp system 2.0 80cm (00853799007701) |
| 00853799007725 - 8F Base Camp system 2.0 90cm | 2024-10-22 8F Base Camp system 2.0 90cm |
| 00853799007732 - 8F Base Camp system 2.0 90cm | 2024-10-22 8F Base Camp system 2.0 90cm; 8F Base Camp system 2.0 90cm (00853799007725) |
| 00853799007749 - FreeClimb 88 catheter, 125cm | 2024-07-09 FreeClimb 88 catheter, 125cm |
| 00853799007756 - FreeClimb 88 catheter, 132cm | 2024-07-09 FreeClimb 88 catheter, 132cm |