| Primary Device ID | 00861283000312 |
| NIH Device Record Key | c1c3c27b-a5d2-4e8e-a38e-061ae7ea819b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SuctionShield |
| Version Model Number | PSC5300 |
| Company DUNS | 193277717 |
| Company Name | PATIENT SHIELD CONCEPTS, LLC |
| Device Count | 100 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00086128000312 [Unit of Use] |
| GS1 | 00861283000312 [Primary] |
| JOL | Catheter And Tip, Suction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-08 |
| 00861283000312 | The holster device provides safe and convenient storage of the Yankauer Suction Tip between suct |
| 00861283000305 | The holster device provides safe and convenient storage of the Yankauer Suction Tip between suct |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUCTIONSHIELD 86794530 5352905 Live/Registered |
Patient Shield Concepts, LLC 2015-10-21 |