| Primary Device ID | 20194717102301 |
| NIH Device Record Key | 2331d4fb-52ee-4dc7-a0e5-0934f905c57f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Regard™ |
| Version Model Number | UR00858B |
| Company DUNS | 117174678 |
| Company Name | ROI CPS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10194717102304 [Primary] |
| GS1 | 20194717102301 [Package] Contains: 10194717102304 Package: [10 Units] In Commercial Distribution |
| PPA | Bladder Irrigation Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-05 |
| Device Publish Date | 2019-10-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REGARD 97196978 not registered Live/Pending |
HealthTensor, Inc. 2021-12-30 |
![]() REGARD 86179619 4824780 Live/Registered |
MPC GROUP LLC 2014-01-30 |
![]() REGARD 86154589 4680759 Live/Registered |
LG Electronics Inc. 2013-12-30 |
![]() REGARD 85721657 4544205 Live/Registered |
Steelcase Inc. 2012-09-06 |
![]() REGARD 85342365 not registered Dead/Abandoned |
Clarke Mosquito Control Products, Inc. 2011-06-09 |
![]() REGARD 85236797 not registered Dead/Abandoned |
M. Z. Berger & Co., Inc. 2011-02-08 |
![]() REGARD 85025545 not registered Dead/Abandoned |
Syngenta Participations AG 2010-04-28 |
![]() REGARD 79033880 3340362 Dead/Cancelled |
Kreon, naamloze vennootschap 2006-12-07 |
![]() REGARD 78773486 not registered Dead/Abandoned |
Frederick Goldman, Inc. 2005-12-14 |
![]() REGARD 78064405 2675687 Dead/Cancelled |
Regard Ventures, LLC 2001-05-18 |
![]() REGARD 77864510 4289323 Live/Registered |
Resource Optimization & Innovation, LLC 2009-11-04 |
![]() REGARD 75742545 not registered Dead/Abandoned |
GARD CORPORATION 1999-10-30 |