| Primary Device ID | 00817688022916 |
| NIH Device Record Key | 13b3552d-ebd9-4d1e-8e2b-57b302669a7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Non-Telescopic PenEvac |
| Version Model Number | ICM-000-0595 |
| Catalog Number | ICM-000-0595 |
| Company DUNS | 616182895 |
| Company Name | I.C. MEDICAL, INC. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com | |
| Phone | 623-780-0700 |
| inquiry@icmedical.com |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817688022916 [Unit of Use] |
| GS1 | 00817688022923 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
[00817688022916]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-27 |
| Device Publish Date | 2020-10-19 |
| 00817688022442 | ICM-000-0564 |
| 00817688022213 | ICM-000-0558 |
| 00817688022190 | ICM-000-0556 |
| 00817688022077 | ICM-000-0550 |
| 00817688022060 | ICM-000-0549 |
| 00817688022022 | ICM-000-0544 |
| 00817688022008 | ICM-000-0540 |
| 00817688020783 | ICM-000-0538 |
| 00817688020752 | ICM-000-0536 |
| 00817688020745 | ICM-000-0534 |
| 00817688020721 | ICM-000-0532 |
| 00817688020707 | ICM-000-0530 |
| 00817688020684 | ICM-000-0528 |
| 00817688020660 | ICM-000-0526 |
| 00817688020646 | ICM-000-0524 |
| 00817688021803 | ICM-000-0522 |
| 00817688020615 | ICM-000-0520 |
| 00817688020592 | ICM-000-0518 |
| 00817688020578 | ICM-000-0516 |
| 00817688020554 | ICM-000-0514 |
| 00817688020530 | ICM-000-0512 |
| 00817688020516 | ICM-000-0510 |
| 00817688020493 | ICM-000-0508 |
| 00817688020417 | ICM-000-0496 |
| 00817688022619 | ICM-000-0580 |
| 00817688022596 | ICM-000-0578 |
| 00817688022572 | ICM-000-0576 |
| 00817688022831 | Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk |
| 00817688022817 | Non-Telescopic PenEvac®, Stainless Steel Blade, 10’ Tube, Universal Connector, Non-Sterile, B |
| 00817688022794 | Non-Telescopic PenEvac®, Stainless Steel Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, |
| 00817688022718 | Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, Non-St |
| 00817688022695 | Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, Non-Sterile, Bulk |
| 00817688022916 | Non-Telescopic PenEvac®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile |
| 00817688022893 | Non-Telescopic PenEvac®, Megadyne E-Z Clean Blade, 10’ Tube, 22 mm to 10 mm Flexible Connecto |
| 00817688023913 | Non-Telescopic PenEvac®, Non-Stick ENT Needle, 10 Foot Tube, Universal Connector & Holster, Ste |
| 00817688023890 | Non-Telescopic PenEvac®, Stainless Steel ENT Needle, 10 Foot Tube, Universal Connector & Holste |
| 00817688024156 | Non-Telescopic PenEvac®-NB , No Blade, 10 Foot Tube, Universal Connector & Holster, Sterile |