| Primary Device ID | 00613703520029 | 
| NIH Device Record Key | fc1039fe-95f3-4417-a5a7-7d1c8d0e13b5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Patient Safe® | 
| Version Model Number | 52001 | 
| Catalog Number | 52001 | 
| Company DUNS | 838024255 | 
| Company Name | RETRACTABLE TECHNOLOGIES, INC. | 
| 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 | false | 
| OTC Over-The-Counter | false | 
| Phone | 888-703-1010 | 
| rtiservice@vanishpoint.com | |
| Phone | 888-703-1010 | 
| rtiservice@vanishpoint.com | |
| Phone | 888-703-1010 | 
| rtiservice@vanishpoint.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00613703520005 [Primary] | 
| GS1 | 00613703520012 [Package] Contains: 00613703520005 Package: Box [40 Units] In Commercial Distribution | 
| GS1 | 00613703520029 [Package] Contains: 00613703520012 Package: Case [4 Units] In Commercial Distribution | 
| FMF | Syringe, Piston | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2018-09-12 | 
| Device Publish Date | 2016-09-22 | 
| 00613703560025 | 60mL Patient Safe® Syringe | 
| 00613703530028 | 30mL Patient Safe® Syringe | 
| 00613703520029 | 20mL Patient Safe® Syringe | 
| 00613703510228 | Patient Safe® Luer Cap | 
| 00613703510020 | 10mL Patient Safe® Syringe | 
| 00613703505026 | 5mL Patient Safe® Syringe | 
| 00613703503022 | 3mL Patient Safe® Syringe | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PATIENT SAFE  77674793  3732661 Live/Registered | Retractable Technologies, Inc. 2009-02-20 | 
|  PATIENT SAFE  77308146  not registered Dead/Abandoned | Retractable Technologies, Inc. 2007-10-19 |