| Primary Device ID | 00817126021013 |
| NIH Device Record Key | e7792578-cb21-4bda-9768-cec7d922697f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atos Medical Inc |
| Version Model Number | 2010-076 |
| Catalog Number | 2010-076 |
| Company DUNS | 008224748 |
| Company Name | ATOS MEDICAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com | |
| Phone | 800-271-0025 |
| info.us@atosmedical.com |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817126021013 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-21 |
| Device Publish Date | 2020-02-13 |
| 00817126021013 | Laryngectomy Pulmonary Kit with Standard Provox LaryTube 10/55 and SolaTone Plus Electrolarynx |
| 00817126021006 | Laryngectomy Pulmonary Kit with Standard Provox LaryTube 9/55 and SolaTone Plus Electrolarynx |
| 00817126020986 | 2010-073 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 10/55 and SolaTone Plus℠|