| Primary Device ID | 30855683006044 |
| NIH Device Record Key | b478a975-899c-45e7-b5de-c106bd1c017a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AQUASONIC 100 |
| Version Model Number | ULTRASOUND TRANSMISSION GEL |
| Catalog Number | 01-08-700189/40483A |
| Company DUNS | 002449593 |
| Company Name | PARKER LABORATORIES INC |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com | |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855683006043 [Unit of Use] |
| GS1 | 30855683006044 [Primary] |
| MUI | Media,Coupling,Ultrasound |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2017-07-05 |
| 00855683006531 | AQUASONIC 100 ULTRASOUND TRANSMISSION GEL 5L |
| 30855683006044 | AQUASONIC 100 ULTRASOUND TRANSMISSION GEL 0.25L |
| 30855683006037 | AQUASONIC 100, 60G TUBE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AQUASONIC 100 85059770 3976863 Live/Registered |
Parker Laboratories, Inc. 2010-06-10 |
![]() AQUASONIC 100 72070244 0691348 Live/Registered |
PARKER LABORATORIES, INC. 1959-03-25 |