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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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SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 CNAP® Monitor 500 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h) 09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h) 09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h) 09120073931368, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073931344, Operator's Manual USA, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0, 2 pcs. Thermal paper, 20-HVZU-00258
CNSystems Medizintechnik GmbH
V1.5
Not in Commercial Distribution

  • 09120073931436 ()
21-FHCN-15536

  • Patient monitoring system module, blood pressure, noninvasive
No Description
OMNIA MEDICAL, LLC
LS810-B
In Commercial Distribution

  • 00843511100711 ()
LS810-B

  • Patient monitoring system module, blood pressure, noninvasive
No Description
MAICO Diagnostics GmbH
MB11 Classic
In Commercial Distribution

  • 04260176120520 ()


  • Evoked-potential audiometer
No Description
MAICO Diagnostics GmbH
MB 11 BERAphone
In Commercial Distribution

  • 04260176120513 ()


  • Evoked-potential audiometer
Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution

  • 00627908090027 ()


  • Evoked-potential audiometer
Electrodes for use with the Aurix system (DI: 00627908080011). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
Vivosonic Inc
100001
Not in Commercial Distribution

  • 00627908080073 ()


  • Evoked-potential audiometer
Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following devices are accessories for use with the Aurix system: 11002 Sound Stimulator DI: 00627908080028 11003 Amplifier DI: 00627908080035 11010 Laptop Computer DI: 00627908080042 100116 Amplifier Lead Cable DI: 00627908080059 ER-3A-AUX Insert Earphones DI:00627908080066 100001 Electrodes DI: 00627908070067 100004 Ear Domes DI: 00627908080080 WA021 Tablet Computer DI: 00627908080097
Vivosonic Inc
AURIX-1
Not in Commercial Distribution

  • 00627908080011 ()


  • Evoked-potential audiometer
Electrodes for use with the Integrity system (DI: 00627908020017). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
Vivosonic Inc
100001
In Commercial Distribution

  • 00627908070067 ()


  • Evoked-potential audiometer
Sound stimulator for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
Vivosonic Inc
ST-800
In Commercial Distribution

  • 00627908020154 ()


  • Evoked-potential audiometer
Dual channel CV-Amp for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017) The UDI is comprised of GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
A91
In Commercial Distribution

  • 00627908020147 ()


  • Evoked-potential audiometer
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