Primary Device ID | 20801741010129 |
NIH Device Record Key | 5dd7134d-d9e7-4dbb-84c5-3b706b35bb19 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Simpulse SOLO |
Version Model Number | 0067570 |
Catalog Number | 0067570 |
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 Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
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 |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00801741010125 [Primary] |
GS1 | 10801741010122 [Package] Contains: 00801741010125 Package: BX [5 Units] In Commercial Distribution |
GS1 | 20801741010129 [Package] Contains: 10801741010122 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 |