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 |