| Primary Device ID | 00847536006317 |
| NIH Device Record Key | f6493d16-7df0-4f22-ba18-2aa9299df34f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EchelonTM |
| Version Model Number | 190-5092-150 |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847536006317 [Primary] |
| KRA | Catheter, continuous flush |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
[00847536006317]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2016-04-03 |
| 00847536006317 | 190-5092-150 ECHELON14 90 PRESHAPE TIP |
| 00847536006294 | 190-5091-150 ECHELON10 90 PRESHAPE TIP |
| 00847536006270 | 145-5092-150 ECHELON14 45 PRESHAPE TIP |
| 00847536006256 | 145-5091-150 ECHELON10 45 PRESHAPE TIP |
| 00847536005983 | 105-5092-150 ECHELON 14 MICRO CATHETER |
| 00847536005969 | 105-5091-150 ECHELON 10 MICRO CATHETER |