| Primary Device ID | 10816765011116 |
| NIH Device Record Key | 1be164db-f87b-4737-be7f-37c325708249 |
| Commercial Distribution Discontinuation | 2020-03-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BioShield |
| Version Model Number | 00711134 |
| Catalog Number | 00711134 |
| Company DUNS | 627879687 |
| Company Name | US Endoscopy |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816765011119 [Primary] |
| GS1 | 10816765011116 [Package] Contains: 00816765011119 Package: Box [50 Units] Discontinued: 2020-03-17 Not in Commercial Distribution |
| ODD | Endoscopic retrograde cholangiopancreatography (ERCP) cannula |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-03-17 |
| Device Publish Date | 2016-09-17 |
| 10816765011147 | The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio |
| 10816765011130 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10816765011123 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10816765011116 | The BioShield irrigator extension tubing is used for attachment to an auxiliary water pump for h |
| 10816765011109 | The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio |
| 10816765011079 | The BioShield biopsy valve - sterile is used to cover the opening to the biopsy/suction channel |
| 10816765011062 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10816765011055 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10816765011031 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 20816765013407 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 20816765013391 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10816765011093 | The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigat |
| 00724995183547 | The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigat |
| 20724995183534 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 20724995183497 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10724995183599 | The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio |
| 10724995183582 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10724995183575 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10724995183568 | The BioShield irrigator extension tubing is used for attachment to an auxiliary water pump for h |
| 10724995183551 | The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio |
| 10724995183520 | The BioShield biopsy valve - sterile is used to cover the opening to the biopsy/suction channel |
| 10724995183513 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10724995183506 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10724995183483 | The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a |
| 10724995199255 | The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channe |
| 10724995199248 | The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channe |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOSHIELD 90503836 not registered Live/Pending |
Sotera 2021-02-02 |
![]() BIOSHIELD 90035009 not registered Live/Pending |
G95 INC. 2020-07-03 |
![]() BIOSHIELD 88845960 not registered Live/Pending |
G95 Inc. 2020-03-24 |
![]() BIOSHIELD 88136155 not registered Dead/Abandoned |
YoungChoon Lim 2018-09-28 |
![]() BIOSHIELD 88064842 5761340 Live/Registered |
Indusco, Ltd. 2018-08-03 |
![]() BIOSHIELD 87499312 5588764 Live/Registered |
Celvitali International, INC. 2017-06-21 |
![]() BIOSHIELD 86748091 not registered Dead/Abandoned |
Pace International, LLC 2015-09-04 |
![]() BIOSHIELD 86359720 not registered Dead/Abandoned |
Covidien LP 2014-08-07 |
![]() BIOSHIELD 86212857 4717898 Live/Registered |
Pentair Water Pool and Spa, Inc. 2014-03-06 |
![]() BIOSHIELD 86121267 not registered Dead/Abandoned |
JOHNSON & JOHNSON 2013-11-18 |
![]() BIOSHIELD 86041977 not registered Dead/Abandoned |
BioHealth Global Industries, Inc. 2013-08-19 |
![]() BIOSHIELD 85825488 4391932 Live/Registered |
Regent Industrial Products, LLC 2013-01-17 |