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V4?>2V40NBL 28<>30< AB0=40@BC EN 455-1, EN 455-2, EN 455-3, EN 455-4. !#/ 2V4?>2V40T <V6=0@>4=><C B0 AB0=40@BC #:@0W=8 ISO 13485.?0@04000843324 - !8AB5<0 4;O ?5@5;820==O @V48= 7030;L=>3> ?@87=0G5==O4=>@07>20 A8AB5<0 4;O 2;820==O V=DC7V9=8E @>7G8=V2, :@>2V B0 :@>2>70<V==8:V2  MEDICARE (Luer slip)4=>@07>20 A8AB5<0 4;O 2;820==O :@>2V, V=DC7V9=8E @>7G8=V2 B0 :@>2>70<V==8:V2 ;O 2=CB@VH=L>25==>3> 2;820==O :@>2V, V=DC7V9=8E @>7G8=V2 B0 :@>2>70<V==8:V2. >268=0 B@C1:8 =5 <5=H5 1500 <<, 4V0<5B@ =5 <5=H5 3,5<<. 83>B>2;5=0 7 ?>;V2V=V;E;>@84C. >2VB@>2V4, I> ?V4:;NG0TBLAO 4> T<=>ABV, A:;040TBLAO 7 <5B0;52>W 3>;:8 B0 ?>2VB@O=>3> DV;LB@C, 283>B>2;5=V 7 <5B0;C B0 ?>;V?@>?V;5=C. @0?5;L=0 :0<5@0 =0?V26>@AB:0 7 DV;LB@><, I> 70157?5GCT 2V7C0;L=> :>=B@>;L>20=5 70?>2=5==O. $V;LB@ 4;O 70?>1V30==O ?@>=8:=5==O =51060=8E G0AB>: e" 80%. (284:VABL ?>B>:C e" 500<;/2E2. 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(284:VABL ?>B>:C e" 1000<;/10E2. @0?5;L=0 :0<5@0 =0?V26>@AB:0 7 DV;LB@>< 70157?5GCT 2V7C0;L=> :>=B@>;L>20=5 70?>2=5==O. $V;LB@ 4;O 70?>1V30==O ?@>=8:=5==O =51060=8E G0AB>: e" 80%. "8? 7 T4=0==O Luer slip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"@L>E:><?>=5=B=89. 1'T< 20,0 <;. @>7>@89 F8;V=4@, :0=N;O 3>;:8 7 :>2?0G:><, 283>B>2;5=V 7 3><>?>;V<5@0 ?>;V?@>?V;5=C. >@H5=L 7V HB>:>< 283>B>2;5=V 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. 'VB:0, ABV9:0 4> AB8@0==O H:0;0. !B>?>@=5 :V;LF5 (1;>:V2=8: ?>@H=O). C<>289 CIV;L=N20G 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. `T<=0 0B@02<0B8G=0 3>;:0 7 B@83@0==8< 703>AB@5==O< B0 :>2?0G:><. >;:0 7 0CAB5=VB=>W =5V@602VNG>W AB0;V. >7<V@ 3>;:8 70 :0;V1@>< 21 G, 1 1/2 B0 <5B@8G=89 @>7<V@ 3>;:8 0,8 E 38<<. "8? 7'T4=0==O C5@ A;V? 01> C5@ ;>:. (?@8F =5 <VAB8BL ;0B5:A. >25@E=O H?@8F0 G8AB0 B0 =5 ?>28==0 <VAB8B8 AB>@>==VE G0AB>:. 8@V1 =5B>:A8G=89 - <VAB8B8 =5 1V;LH5 5<3/; A28=FN, >;>20, 70;V70, 0 :04<VN =5 1V;LH5 0,1<3/;. 5@B289 ?@>ABV@ =5 1V;LH5 0,15 <;. <07:0 =5 ?><VB=0, :V;L:VABL =5 ?5@528ICT 0,25 <3/A<. !B5@8;L=89, =5B>:A8G=89 B0 0?V@>35==89. ;O >4=>@07>2>3> 28:>@8AB0==O. =482V4C0;L=5 ?0:C20==O 35@<5B8G=5 B0 FV;VA=5. V4?>2V40T 28<>30< ISO 7886-1, ISO 7864. 83>B>2;5=89 73V4=> 28<>3 AB0=40@BC !"# ISO 13485.HBC:0170001247017 - (?@8F 7030;L=>3> ?@87=0G5==O, @07>2>3> 70AB>AC20==O(?@8F V='T:FV9=89 >4=>@07>2>3> 28:>@8AB0==O, ;CT@ A;V? "MEDICARE", 5,0 <; (B@L>E:><?>=5=B=89, 7 3>;:>N 0,7 x 38 <<)(?@8F >4=>@07>289 3-:><?>=5=B=89 5 <; 7 3>;:>N 0,7 E 38 << (22GE1 1/2'') ;O ?@>2545==O 2=CB@VH=L>25==8E B0/01> 2=CB@VH=><`O7>28E V= T:FV9. "@L>E:><?>=5=B=89. 1'T<>< 5,0 <;. @>7>@89 F8;V=4@, :0=N;O 3>;:8 7 :>2?0G:><, 283>B>2;5=V 7 3><>?>;V<5@0 ?>;V?@>?V;5=C. >@H5=L 7V HB>:><, 283>B>2;5=V 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. 'VB:0, ABV9:0 4> AB8@0==O H:0;0. !B>?>@=5 :V;LF5 (1;>:V2=8: ?>@H=O). C<>289 CIV;L=N20G 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. `T<=0 0B@02<0B8G=0 3>;:0 7 B@83@0==8< 703>AB@5==O< B0 :>2?0G:><. >;:0 7 0CAB5=VB=>W =5@602VNG>W AB0;V. >7<V@ 3>;:8 70 :0;V1@>< 22 G, 1 1/2 B0 <5B@8G=89 @>7<V@ 3>;:8 0,7 E 38<<. 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