| Primary Device ID | 10801741010177 |
| NIH Device Record Key | fa40ad3b-b306-4789-9672-8d8a4b08d621 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simpulse SOLO |
| Version Model Number | 0067500 |
| Catalog Number | 0067500 |
| Company DUNS | 001191048 |
| Company Name | Davol 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 | 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 | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741010170 [Primary] |
| GS1 | 10801741010177 [Package] Contains: 00801741010170 Package: BX [5 Units] In Commercial Distribution |
| GS1 | 20801741010174 [Package] Package: CA [2 Units] In Commercial Distribution |
| FQH | LAVAGE, JET |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2015-12-23 |
| 20801741010181 | The Simpulse SOLO Wound Management Kit with VariCare Retractable Splash Shield Wound Tip |
| 10801741010177 | The Simpulse SOLO System with Ultrex Retractable Splash Shield Tip |
| 10801741010153 | The Simpulse SOLO System with Ultrex Retractable 1-1/4" Splash Shield Tip |
| 10801741010146 | The Simpulse SOLO System with Showerhead Tip |
| 10801741010139 | The Simpulse SOLO System with Soft Splash Shield Tip |
| 20801741010129 | The Simpulse SOLO Suction/Irrigator |
| 20801741000373 | The Simpulse SOLO System with Ultrex Retractable Splash Shield Tip |