| Primary Device ID | 00817613020130 |
| NIH Device Record Key | ec619b33-36d2-48ba-a008-61db091a7ac1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4Klearity |
| Version Model Number | P-4KR100 |
| Company DUNS | 051244569 |
| Company Name | MED X CHANGE, INC. |
| 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 | false |
| Lot Batch | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817613020130 [Primary] |
| 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 | 2018-02-23 |
| 00817613020550 | 4Klearity Med X brand |
| 00817613020420 | 4Klearity Med X Change Brand |
| 00817613020369 | 4Klearity Med X Change Brand |
| 00817613020253 | 4Klearity Med X brand |
| 00817613020130 | Accessory Pack for 4KR100 |
| 00817613020604 | 4Klearity Med X Change Brand |
| 00817613020796 | 4Klearity Med X Change Brand |
| 00817613020758 | 4Klearity Med X Change brand |
| 00817613020697 | 4Klearity Smith & Nephew Brand |
| 00817613021045 | 4Klearity Med X Change brand |
| 00817613021038 | 4Klearity Med X Change Brand |
| 00817613021021 | 4Klearity Med X Change Brand Software Version 7.12.1.2 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() 4KLEARITY 87445399 5382591 Live/Registered |
Med X Change, Inc. 2017-05-11 |