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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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Holter Kit (Wi-Fi Only) - 00850490007511

Contains VistaPhone (Wi-Fi Only) with protective case, charger, charge cable, Adhesive Overlay, Alcohol Wipes, Adhesive Removal Pads
Vital Connect, Inc.
2400-01
In Commercial Distribution

  • 00850490007511 ()
2400-01

  • Telemetric electrocardiographic ambulatory recorder

BodyGuardian Kit - 00852132007491

BodyGuardian Mini Plus SL CEM Lite Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-66
In Commercial Distribution

  • 00852132007491 ()


  • Medical networking interface unit

BodyGuardian Kit - 00852132007453

BodyGuardian Mini Plus EL CEM Lite Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-67
In Commercial Distribution

  • 00852132007453 ()


  • Medical networking interface unit

BodyGuardian Kit - 00852132007446

BodyGuardian One 4G VZW Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-46
In Commercial Distribution



  • Medical networking interface unit

BodyGuardian Kit - 00852132007439

BodyGuardian Mini Plus EL Lite Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-53
In Commercial Distribution

  • 00852132007439 ()


  • Medical networking interface unit

BodyGuardian Kit - 00852132007422

BodyGuardian Mini Plus EL Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-64
In Commercial Distribution



  • Medical networking interface unit

BodyGuardian Kit - 00852132007415

BodyGuardian Mini Plus SL Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-45
In Commercial Distribution



  • Medical networking interface unit

BodyGuardian Kit - 00852132007408

BodyGuardian Mini Holter SL Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-44
In Commercial Distribution



  • Medical networking interface unit

BodyGuardian Kit - 00852132007392

BodyGuardian Mini Holter EL Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-63
In Commercial Distribution



  • Medical networking interface unit

BodyGuardian One - 00852132007248

BodyGuardian One Remote Monitoring System
PREVENTICE TECHNOLOGIES, INC.
BG3003
In Commercial Distribution

  • 00852132007248 ()


  • Medical networking interface unit
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