| Primary Device ID | 50604351636014 |
| NIH Device Record Key | 030a22a5-3020-4228-b5c5-e617d1857d29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ombra® |
| Version Model Number | Compressor Kit, DME, Child |
| Company DUNS | 056332380 |
| Company Name | MONAGHAN MEDICAL CORPORATION |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com | |
| Phone | 518-561-7330 |
| customerservice@monaghanmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00604351636019 [Primary] |
| GS1 | 50604351636014 [Package] Contains: 00604351636019 Package: [1 Units] In Commercial Distribution |
| BTI | Compressor, Air, Portable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-17 |
| Device Publish Date | 2018-08-15 |
| 50604351637011 | Compressor Kit, DME, Adult |
| 50604351636014 | Compressor Kit, DME, Child |
| 50604351635062 | Tabletop Compressor System |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OMBRA 98256862 not registered Live/Pending |
Letright Industrial Corp., Ltd. 2023-11-06 |
![]() OMBRA 97330068 not registered Live/Pending |
warnicki, jonathon 2022-03-25 |
![]() OMBRA 97146569 not registered Live/Pending |
Zhong, Zhuangqi 2021-11-29 |
![]() OMBRA 97146377 not registered Live/Pending |
Del Fresco Produce Ltd. 2021-11-29 |
![]() OMBRA 88886795 not registered Live/Pending |
511 Solutions LLC 2020-04-24 |
![]() OMBRA 88222241 not registered Live/Pending |
ALDI Inc. 2018-12-09 |
![]() OMBRA 87146002 not registered Dead/Abandoned |
OMsignal Inc. 2016-08-22 |
![]() OMBRA 85782545 4632937 Live/Registered |
Trudell Medical International 2012-11-19 |
![]() OMBRA 85212561 4584734 Live/Registered |
Trudell Medical International 2011-01-07 |
![]() OMBRA 85206047 4218542 Dead/Cancelled |
Pulp Studio, Inc. 2010-12-27 |
![]() OMBRA 79223192 5494751 Live/Registered |
Coats & Clark Inc. 2017-11-02 |
![]() OMBRA 79169077 5188721 Live/Registered |
Giovanni Gregoletto 2015-04-28 |