Xov xwm

Unique device identification (UDI) yog "cov cuab yeej kho mob tshwj xeeb" tsim los ntawm US Food and Drug Administration. Kev ua raws li txoj cai sau npe yog txhawm rau txheeb xyuas cov khoom siv kho mob tau muag thiab siv hauv Asmeskas kev lag luam, txawm tias lawv tsim tawm qhov twg. . Thaum ua tiav, NHRIC thiab NDC cov ntawv yuav raug tshem tawm, thiab txhua yam khoom siv kho mob yuav tsum tau siv cov ntawv sau npe tshiab no ua lub logo rau ntawm cov khoom ntim sab nraud. Ntxiv rau qhov pom, UDI yuav tsum txaus siab rau cov ntawv nyeem thiab tsis siv neeg txheeb xyuas thiab cov ntaub ntawv ntes (AIDC). Tus neeg saib xyuas kev sau npe yuav tsum xa cov ntaub ntawv tseeb rau txhua yam khoom mus rau "FDA International Specialty Medical Center". Cov cuab yeej txheeb xyuas cov ntaub ntawv UDID" ua rau cov pej xeem nug thiab rub tawm cov ntaub ntawv cuam tshuam (nrog rau cov ntaub ntawv los ntawm kev tsim khoom, kev faib tawm rau cov neeg siv khoom, thiab lwm yam) los ntawm kev nkag mus rau hauv cov ntaub ntawv, tab sis cov ntaub ntawv yuav tsis muab cov ntaub ntawv siv rau cov neeg siv khoom. 

Feem ntau yog tus lej uas muaj cov lej lossis cov ntawv. Nws suav nrog tus lej cim npe (DI) thiab tus lej tsim khoom (PI).

Cov cuab yeej txheeb xyuas tus lej yog qhov yuav tsum tau ua kom ruaj khov, uas suav nrog cov ntaub ntawv ntawm cov neeg ua haujlwm tswj xyuas daim ntawv lo, cov qauv tshwj xeeb lossis cov qauv ntawm cov cuab yeej, thaum cov khoom lag luam qhia tsis tau tshwj xeeb, thiab suav nrog cov cuab yeej tsim khoom, tus lej xov tooj, hnub tsim khoom, hnub tas sij hawm thiab kev tswj xyuas raws li cov khoom siv. Cov cim cim cim ntawm cov khoom nyob hauv cov ntaub so ntswg.

Tom ntej no, cia peb tham txog GUDID, Ntiaj Teb Lub Cim Cim Cim Cim Cim Cim Txheej Txheem (GUDID), FDA International Special Medical Device Identification Library. Cov ntaub ntawv tau tshaj tawm rau pej xeem los ntawm AccessGUDID query system. Tsis tsuas yog koj tuaj yeem nkag ncaj qha rau DI code ntawm UDI hauv daim ntawv lo rau ntawm lub vev xaib database kom pom cov ntaub ntawv khoom, tab sis koj tuaj yeem tshawb xyuas los ntawm cov yam ntxwv ntawm txhua yam khoom siv kho mob (xws li tus lej cim, tuam txhab lossis lub npe lag luam, generic lub npe, los yog tus qauv thiab version ntawm lub cuab yeej). ), tab sis nws tsim nyog sau cia tias cov ntaub ntawv no tsis muab PI cov lej rau cov khoom siv.

Ntawd yog, lub ntsiab lus ntawm UDI: Unique Device Identification (UDI) yog ib qho kev qhia uas muab rau cov cuab yeej kho mob thoob plaws hauv nws lub neej, thiab nws tsuas yog "daim npav ID" hauv cov khoom lag luam. Kev txais yuav thoob ntiaj teb ntawm kev sib koom ua ke thiab tus qauv UDI yog qhov muaj txiaj ntsig los txhim kho cov saw hlau pob tshab thiab kev ua haujlwm zoo; nws yog qhov zoo los txo cov nqi khiav haujlwm; Nws yog qhov zoo rau kev paub txog kev sib qhia thiab kev sib pauv; Nws yog qhov zoo rau kev saib xyuas cov xwm txheej tsis zoo thiab rov qab los ntawm cov khoom tsis zoo, txhim kho cov kev pabcuam kho mob zoo, thiab tiv thaiv cov neeg mob kev nyab xeeb.