Central Drugs Standard Control Organisation

1 CentralDrugsStandardControlOrganisationD irectorateGeneralof HealthServicesMini~tryC?tf-I~~ltlJ_&.FCl milyWelfareFoodandDrugAdministrationBhaw anKotla-Road,-NewDelhi-l10002 TyTheCommissioner,Food"&DrugsControlAdmi nistration,GujaratState, ,BlockNo:8,.1stFloor, :- Approvalforadditionallistof products(DifferentTypesof Catheter& )in respectof , 4804 Phase-IV, , )--DrugsControllerGenral (1),lIcCopyfor informationandnecessaiyaction:-'_H_~ ~--------------);> (I),Sub-ZonalOffice,CentralDrugStandards ControlOrgan1?ation,Old'TermiFlalBUildIn g,AirCarg6 Comple~jAirport,Ahmedabad-380003G" ProductNewMedicalDevicesto be Manufacturedby , 4804,Phase-IV, ,Vatva,~Abmedabad.,,382445., ::E~ 'G'-& '(:>1.! -EXCLUDlNGSCHEDULE" X"UNDERLICENCEIN - - ~-_G/28/-'l-357.

2 U. }.'\)cJt~.0Y~ )-~~-=~ \ \'-~Q\S'\----ENCLOSURE-2~cF,emmissiofJer Food& DrsnfrolAdministra! .~5-]Ar\ ,fGR__QrygSContr-O!lsr oeml(lndiaf'- -- - - .MlnlslryofHealth& Famil"WelfareFDAB hawan,KotlaRoad, ( , ,Phase-IV, ,Vatva,Ahmedabad-382445.,UNDERSCHEDULE'C '& 'C1'EXCLUDINGSCHEDULEIIX '\)cJ~c'\J~-w c9,~ \"~O\s." (INTRAVENOUSCANNULA)-size:G:14,16,18,20, 22,24, 'sTube-size:FG:8,10,12,14,16,18,20, :8,10,12,14,16,18,20,22, 'sTube-sizeG:8,10,12,14,16,18,20,22, :4,5,6,7,8,10,2,14,16, :10, WithoutAdaptor-size'sFG:4,5,6,7,8, WithoutCuff-size' ,3, ,4, ,5, ,6, ,7, ,8, , WithoutCuff-size' ,3, ,4, ,5, ,6, ,7, ,8, , :8,10,12,14,16,18, (rf:1-f".'-"",r . ListOfAdditional' , ,Phase-IV, ,Vatva,Ahmedabad-382445.

3 ,UNDERSCHEDULE'c'&'C1'EXCLUDINGSCHEDULE" X"UNDERLICENCEIN "_. ~,.\'\J oj\(..\v~ .-ro ':J \.\.- \\ - ~ 0 \ S"E N :4,6,8,9,10,12,14,16,18, ~ril~ ; ~TA_LCATHETER-sizeFG:4,6,8,9,10,12,14,16 ,18~2b,22, :4,6,8,10,12,14,16,18,20,22, :4,5,6,7,8,9, :6,8,10,12,14,16,18,20,22,24,26,28,30,32 ,34,36, ~sizeFG:12,14,16,18,20,22,24,26,28,30,32 ,34,36, BloodTubingSetArterialVenousTubingSet-si ze:Arterial1 sizeFG:12,14,16,18,20,22,24,26,28,30,32, 34,36, ,CatheterSterileDisposablesingleuseNASAL OXYGENCANNULA- i'J, 'of',eneral(India)--MmistryofHe~' ! "an,KotlaRoadiTn~ '1 SWDelhi-110002,'-','-~-----~~~~--~------ -----~----~--~~--~---~----------~-----,. .~FiCIis-sione" :' I_____,___ - ug, .Olli olAdmifiistrafiat;,GfJ)aratState.

4 , , ,Phase-IV, ,Vatva,Ahmedabad-382445.,UNDERSCHEDULE'C '&'C1"EXCLUDINGSCHEDULE" X"UNDERLICENCE! \JCL~ido'V~~\i.~,\'2iO\~'-,\.ENeLOSU R E- (INTRAVENOUSCANNULA)-size:G:14,16,18,20, 22,24,26.("DISPOTOUCH"Brand) 'sTube-size:FG:8,10,12,14,16,18,20, " " :8,10,12,14,16,18,20,22,24."DISPOTOUCH"B rand\' 'sTube-sizeG:8,10,12,14,16,18,20,22,24.( "DISPOTOUCH" Brand) :4,5,6,7,8,10,2,14,16,18."DISPOTOUCH" :10,12.("DISPOTOUCH" Brand) WithoutAdaptor-size'sFG:4,5,6,7,8,10.("D ISPOTOUCH" Brand) WithoutCuff-size' ,3, ,4, ,5, ,6, ,7, ,8, ,9.("DISPOTOUCH" Brand) SterileDisposablesingleuseTRACHEOSTOMYTU BEWith& WithoutCuff-size' ,3, ,4, ,5, ,6, ,7, ,8, ,9.("DISPOTOUCH"Brand) :18,19,20,21,22,23,24,25,26,27."DISPOTOU CH" '~8,10,12,14,16,18,20.

5 ~o\j("DISPOTOUCH" Brand).ft!'J :atheterSterileDisposablesingleuseNELATO N ATHETER.:sizeF4,5,6,7,8,10,12,14,16,18,2 0.("DISPOTOUCH"Brand)~~ ~GiiWw'. 4,6,8,10,12;14,16,18,20.(" "--BJaodJ_~ ~c~_'\.'?*a-. ----~ ~ __ ._ .. ,,~.~k."", ..JDrGNSiNGHC ontrol!~!q_~r1er !f1c!jC3)')r;:'::;S~;;hi[:; , ,Phase-IV, ,Vatva,Ahmedabad-382445.,UNDERSCHEDULE'C '&'C1'EXCLUDINGSCHEDULE" X" ~--~--------- -~--------- - - - - ,..f~ t-------f-\" ,t-t--~--~------=------~--;,------------ ---------------. \Jailc~0~'<tV&""-\..\\':=20\~' :4,6,8,9,10,12,14,16,18,20,("DISPOTOOCH" Brand)'. :4,6,8,9,10,12,14,16,18,20,22,24.("DISPO TOUCH"Brand) :4,6,8,10,12,14,16,18,20,22,24."DISPOTOU CH"Brand) :4,5,6,7,8,9,10.("DISPOTOUCH" :6,8,10,12,14,16,18,20,22,24,26,28,30,32 ,34,36,40.]

6 ("DISPOTOUCH" Brand) :12,14,16,18,20,22,24,26,28,30,32,34,36, 40."DISPOTOUCH"Brand) ("DISPOTOUCH"Brand) ! :ArterialI Various("DISPOTOUCH" Brand) sizeFG:12,14,16,18,20,22,24,26,28,30,32, 34,36,40.("DISPOTOUCH" :AdultIPediatric"DISPOTOUCH"Brand)24 SterileDisposableThreeWayStopCock(Brand: DISPOTOUCH"ForSinIeuse"25~teriJeDisposab leExtensionTube(Hfand:DISPOTOUCH)"liF"or S}nleuse'"I~ ~~~~e. lu!at?rasa Acces"'yofInfusionSet~.( )"t-orSmIeu"..~.0,,-2"1-- -Sterile'"p()sabj~Exten~igrrlil' ~__s'SC[r:srpnIT--'on~Se[------~-~----~- ----nd:DfSp6t()Uci-l). ~'Fingleuse" > .{~'h-CO"'1~LfJ+:, ~._~ '--, .. FamilyWelfareFood& DrugsAdministrationBhawan,KotlaRoad, [AA7MD7MS7a172012~DtTo,//'TheJointCommis sioner( ),FoodandAdministration, , ,Hospital,4thFloor, ,WagleEstate,Thane- tI, tR"fl11- t\d\Lv SUB:- Drugs & CosmeticAct1940& RulesthereunderApprovalforgrantofmanufac turinglicenceinForm28(NonSteileOrthopaed iclmpiants)in -respect-ofM/sYogeswarlmplants(l), pvtttd;D~2,KothariCompound,5 Acres-ThikujiniWadiRoad,Manpada,thane(\/ yest)Maharashtra- ,dulyapprovedbyCentralLicenceApprovingAu thority(CLAA) ; (length,diameter),MaterialofConstruction ,shelflife.]]]

7 Thelicencealsodoesnotspecify, , ' faithfully,------------------------D-r-U -g-s-~_~~~- -~---CopyforInformationandnecessaryactio nto:->- (I),CentralDrugStandardsControlOrganisat ion,West~one,4thFloor,FDAB havan,GJMSDC ompound,.BellasisRoad,MumbaiCentral, ,.--- -",-_\"1 .""-" , , , (SeeRule76)Licencetomanufactureforsale[o rfordistributionof J drugsspecifiedinSchedulesC andC(1)[ : 9"~W_____1,~j111S~..Y_QGES_t:l~ARJMaANTS (I }-PVl". (West)MAHARASHTRA thefollowingdrugs,beingdrugsspecifiedinS chedulesC andC(1)[excludingthosespecifiedinSchedul eXl totheDrugsandCosmeticsRules,1945 ~ndCosticsAct,1940.~" ,.. ( ..~~.~:.f:~!:J.~DrugsControl!General(I~d ia). ,(KonkanDivision) Health~eMCes.))]]]

8 ~d& 'stt"DatedOfissue- Q~! ~ ~." ~Ith&. '.)'II)"t'..'l L.!.;;qon,FOAB hawan,KallaRoad,:. , iane""~ shallbekeptontheapprovedpremisesandshall beproducedatthe~'(j()a1r:iclorappointedu ndertheDrugsandCosmeticsAct, :/~>-r'-----"' .. thosespecifiedinScheduleXlnotIncludedabo ve,hesmiJ1dapphe-Lic~nsAuthorityforthene cessaryendorsemenLasprovidel~{Ule75(hisl icenF~'1 Ibedeemedtoextendtotheitem~_~Q_em:lQ[~e- ,:t.\~\ !.. ~-::=-~nY:ch~n eintheexp:rt-tt~lb:./th~ ~b!tl:l6r1tt ritingintheeventofanychangeinntheconstit utionofthefirmtiifgI~ ]aKesplace_icenceshallbedeemedtobevalidf oramaximumperiodofthreemonthsfromthedate onwhichthechangetakesplaceunless,"inthem ea'ntime,a ~risingAuthorityinthenan' (I)--_c_-,-_c--PVi:tiDat 0/2,KOTf'tAfttet>MP<:>ttND;-S-ACRES;MANPADA,THANE(W).}

9 Underlicensein.,theform28to begranted.~1. YOGESHWAR- . BonePlat~.-3.. ~!.yQg]~ . YOGES.~.. -builtimlants- -_ .. --- --_."--"' ~. "..- .._---,~."~-".. , ~..~~ I. N"~lf~JN~=l1~I)..9, (Hulllertisnail). (F~murNail); ~ "C" ,anyadditionor anyde1etionof productwillnot1)ecarried~ut; ..;-2. Weunderstandto complywithall theprovisionof theActsin forceand==-=====-~dfrernOlfSis$tredfrOrt lTti~~to-~MtcertsiniA~Ihgd! ~J1 Rfacture-aI1 YPI9cfLlctllrr@rn~m~e-c~t'()l'lgtrrg1o-c t(lOthe r Weundertakenotto manufactureor sellor distributeanyproductevenif it is-=----~~~.~~.~~=~=~-=_'-~J. ltruaea~Xn~approvetrrfst~oEprQQUaJ:{Ins: o[;a ;~ocr" ba nne'dby=~__--==----__ IM;~I}~ ! ~~= -c.

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