Kum 20 13 khan Food and Drug Administration (FDA) chuan dan hnuhnung ber a tichhuak a, chu chuan device identification system danglam tak, distribution leh hmanna hmanga devices te hriat chian tawk tura ruahman a siam a ni. Rule hnuhnung berah chuan device labeler-te chuan device label leh package-ah device identifier (UDI) danglam bik an dah tur a ni a, chu chu rule-in exception emaw, alternative emaw a pekna hmunah chauh a ni. UDI tin hi plain-text version leh automatic identification leh data capture (AIDC) technology hmanga pek tur a ni. UDI pawh hi hmanna hmun khat aia tam atana ruahman, hman apianga hman tan tum, hmanruaah direct-a chhinchhiah a ngai dawn bawk a ni. Device label leh package-a date te chu international standard leh international practice nena inmil standard format-a tarlan tur a ni.
UDI hi numeric emaw alphanumeric code danglam tak a ni a, a then hnih a awm a ni:
Device Identifier (DI), UDI pakhata labeler leh device pakhata specific version emaw model emaw hriat theihna tur, tih ngei ngei tur, tih ngei ngei tur, tih tur, leh .
A production identifier (PI), UDI pakhata conditional, variable portion, device pakhat label-a telh a nih chuan a hnuaia mi pakhat emaw, a aia tam emaw hriat theihna tur:
Device siam chhuahna lot emaw batch number emaw;
hmanrua bik serial number;
hmanrua bik hman hun tawp hun tur;
hmanrua bik siam a nih ni;
Mihring cell, tissue, emaw cellular leh tissue-based product (HCT/P) chu device anga regulate a nih chuan §1271.290(c)-in a mamawh identification code danglam tak.
UDI zawng zawng hi FDA-accredited issuing agency-in a enkawl system hnuaiah tihchhuah vek tur a ni. Rule hian diltuin FDA accreditation a zawn theihna tur process a pe a, diltuin FDA hnena a pek tur thu a tarlang a, dilna endikna atana FDA-in a hman tur criteria chu a tarlang bawk.
Exception leh alternative thenkhat chu dan hnuhnung berah tarlan a ni a, chu chuan a senso leh phurrit chu a tlem berah a dah theih nan a enkawl a ni. UDI system chu stage hrang hrangah hman tan a ni ang a, kum sarih chhung atan, a taka kalpui a nih theih nan leh hun kal zelah a hmanna tur sum senso leh phurrit te chu vawi khatah absorb vek a ngai tawh lo tur a ni.
System-a tel ve angin, device labeler-te chuan FDA-in administered global unique device identification database (GUDID)-ah information an thehlut tur a ni. Gudid hian UDI nei device tin tan standard set of basic identifying elements a keng tel ang a, DI chauh a nei ang a, chu chu database-a device information hmuh theihna tur key atan a tangkai ang. PI hi Gudid-ah hian a tel lo.
FDA chuan he thu hi a tam zawk chu AccessGudid-ah mipui tan a pe chhuak mek a, National Library of Medicine nena thawhhona hmangin. Medical device hmangtute chuan AccessGuDid hmangin device chungchanga information an zawn emaw, an download emaw thei a ni. UDI chuan a tarlang lo va, Gudid database-ah chuan, mimal chanchin hriat theihna tur device-te pawh telna, tu nge tih hriat tur eng emaw zat a awm dawn lo.
Gudid leh UDI chungchang hrechiang duh tan Udi Resources page ah hian helpful education module, guidances, leh UDI nena inzawm thil dangte link i hmu ang.
A 'labeler' chu mi tu pawh, device-a label vuah tirtu, emaw, device pakhat label siam danglam tirtu, a hnua label thlak emaw, siam danglam emaw ngai lovin, device chu sumdawnna atana sem chhuah tumna nen a ni. Device semtu hming, leh contact information tih belh chu, label-a tihdanglam dang siam lovin, mi pakhat chu labeler a nih leh nih loh hriatfiahna atana siam danglamna a ni lo. A tam zawkah chuan labeler chu device siamtu a ni ang a, mahse labeler chu specification developer, single-use device reprocessor, convenience kit assembler, repackager, emaw relabeler emaw a ni thei.
Automatic Identification and Data Capture (AIDC) tih hian Electronic Patient Record emaw computer system dang emaw automated process hmanga a luh theih tur form-a device UDI emaw device identifier emaw a thlen theihna tur technology eng pawh a kawk a ni.
