Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SL3 CPX, VC PS BE SELECTO 3
Bernafon AG
136445
In Commercial Distribution

  • 05711584051412 ()


  • Air-conduction hearing aid, behind-the-ear
SL3 CP, VC PS BE SELECTO 3
Bernafon AG
136443
In Commercial Distribution

  • 05711584051405 ()


  • Air-conduction hearing aid, behind-the-ear
SL5 CPX, VC PS MAC SELECTO 5
Bernafon AG
136457
In Commercial Distribution

  • 05711584051290 ()


  • Air-conduction hearing aid, behind-the-ear
SL5 CP, VC PS MAC SELECTO 5
Bernafon AG
136449
In Commercial Distribution

  • 05711584051252 ()


  • Air-conduction hearing aid, behind-the-ear
SL5 CP, VC PS DB SELECTO 5
Bernafon AG
136448
In Commercial Distribution

  • 05711584051245 ()


  • Air-conduction hearing aid, behind-the-ear
Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided: "B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
Polymap Wireless
GMA2-L
In Commercial Distribution

  • 00861700000376 ()


  • Medical networking interface unit
Cable to connect Polytel PWR-09-02 GMA2 to Bayer family glucose meters
Polymap Wireless
"B" cable for GMA2
In Commercial Distribution

  • 00861700000369 ()
RYPLX03

  • Medical networking interface unit
Cable to be used with Polytel PWR-09-02 GMA2 to support Abbott glucose meters
Polymap Wireless
"A" cable for GMA2
In Commercial Distribution

  • 00861700000352 ()
RPLYX02

  • Medical networking interface unit
This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters from LifeScan
Polymap Wireless
"L" cable for GMA2
In Commercial Distribution

  • 00861700000345 ()
RPLYX01

  • Medical networking interface unit
Glucose meter accessory providing Bluetooth connectivity for existing glucose meters. Depending on which cable is provisioned, this device supports different existing glucose meters. "L" cable: LifeScan OneTouch Ultra, Ultra2, UltraMini, UltraEasy, Select, Basic "B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
Polymap Wireless
PWR-09-02
In Commercial Distribution

  • 00861700000338 ()


  • Medical networking interface unit
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Abbott. Specific meters supported are FreeStyle Lite and FreeStyle Freedom Lite
Polymap Wireless
PWR-08-09
In Commercial Distribution

  • 00861700000321 ()


  • Medical networking interface unit
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ.
Polymap Wireless
PWR-08-07
In Commercial Distribution

  • 00861700000314 ()


  • Medical networking interface unit
SL5 CPX, VC PS BE SELECTO 5
Bernafon AG
136444
In Commercial Distribution

  • 05711584051214 ()


  • Air-conduction hearing aid, behind-the-ear
SL5 CP, VC PS BE SELECTO 5
Bernafon AG
136442
In Commercial Distribution

  • 05711584051207 ()


  • Air-conduction hearing aid, behind-the-ear
CA3 ITCPD, WL L BE CARISTA 3
Bernafon AG
132571
In Commercial Distribution

  • 05711584051023 ()


  • Air-conduction hearing aid, canal
CA3 ITCPD, WL R BE CARISTA 3
Bernafon AG
132570
In Commercial Distribution

  • 05711584051016 ()


  • Air-conduction hearing aid, canal
CA3 ITCD, WL L BE CARISTA 3
Bernafon AG
132567
In Commercial Distribution

  • 05711584051009 ()


  • Air-conduction hearing aid, canal
CA3 ITCD, WL R BE CARISTA 3
Bernafon AG
132566
In Commercial Distribution

  • 05711584050996 ()


  • Air-conduction hearing aid, canal
CA3 ITC, L BE CARISTA 3
Bernafon AG
132563
In Commercial Distribution

  • 05711584050989 ()


  • Air-conduction hearing aid, canal
CA3 ITC, R BE CARISTA 3
Bernafon AG
132562
In Commercial Distribution

  • 05711584050972 ()


  • Air-conduction hearing aid, canal
CA3 ITED, WL L BE CARISTA 3
Bernafon AG
132575
In Commercial Distribution

  • 05711584050965 ()


  • Air-conduction hearing aid, canal
CA3 ITED, WL R BE CARISTA 3
Bernafon AG
132574
In Commercial Distribution

  • 05711584050958 ()


  • Air-conduction hearing aid, canal
CA3 CIC, BE CARISTA 3
Bernafon AG
132559
In Commercial Distribution

  • 05711584050941 ()


  • Air-conduction hearing aid, canal
CA3 CICP, BE CARISTA 3
Bernafon AG
132557
In Commercial Distribution

  • 05711584050934 ()


  • Air-conduction hearing aid, canal
SOUNDGATE 2.0, NO LOGO
Oticon A/S
131233
In Commercial Distribution

  • 05711584050361 ()


  • Hearing aid neck induction loop, wireless input
SOUNDGATE 2.0, BERNAFON
Bernafon AG
131231
In Commercial Distribution

  • 05711584050354 ()


  • Hearing aid neck induction loop, wireless input
PC7 CPX, VC PS MAC PRECISO 7
Bernafon AG
131941
In Commercial Distribution

  • 05711584050323 ()


  • Air-conduction hearing aid, behind-the-ear
PC7 CPX, VC PS DB PRECISO 7
Bernafon AG
131940
In Commercial Distribution

  • 05711584050316 ()


  • Air-conduction hearing aid, behind-the-ear
PC7 CPX, VC PS GB PRECISO 7
Bernafon AG
131939
In Commercial Distribution

  • 05711584050309 ()


  • Air-conduction hearing aid, behind-the-ear
PC7 CPX, VC PS GR PRECISO 7
Bernafon AG
131938
In Commercial Distribution

  • 05711584050293 ()


  • Air-conduction hearing aid, behind-the-ear
PC7 CPX, VC PS BE PRECISO 7
Bernafon AG
131937
In Commercial Distribution

  • 05711584050286 ()


  • Air-conduction hearing aid, behind-the-ear
TEE ultrasound probe, single use, EO Sterile
IMACOR INC
ClariTEE
In Commercial Distribution

  • 00861589000108 ()
  • 20861589000102 ()
CLT-010

  • Hand-held ultrasound imaging system, body-surface
PC9 CPX, VC PS MAC PRECISO 9
Bernafon AG
131936
In Commercial Distribution

  • 05711584050194 ()


  • Air-conduction hearing aid, behind-the-ear
PC9 CPX, VC PS DB PRECISO 9
Bernafon AG
131935
In Commercial Distribution

  • 05711584050187 ()


  • Air-conduction hearing aid, behind-the-ear
PC7 CP, VC PS MAC PRECISO 7
Bernafon AG
131822
In Commercial Distribution

  • 05711584050057 ()


  • Air-conduction hearing aid, behind-the-ear
PC7 CP, VC PS DB PRECISO 7
Bernafon AG
131821
In Commercial Distribution

  • 05711584050040 ()


  • Air-conduction hearing aid, behind-the-ear
AR7 ITCD, WL R BE ACRIVA 7
Bernafon AG
127859
In Commercial Distribution

  • 05711584049051 ()


  • Air-conduction hearing aid, canal
AR7 ITED, WL L BE ACRIVA 7
Bernafon AG
127871
In Commercial Distribution

  • 05711584049037 ()


  • Air-conduction hearing aid, in-the-ear
AR7 CIC, BE ACRIVA 7
Bernafon AG
127815
In Commercial Distribution

  • 05711584049013 ()


  • Air-conduction hearing aid, canal
AR9 IIC, BL ACRIVA 9
Bernafon AG
127848
In Commercial Distribution

  • 05711584048993 ()


  • Air-conduction hearing aid, canal
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