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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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Amplion Care Assurance - 00850016398253

Smart Room Controller (SRC), Version 1.2, with Audio
AMPLION CLINICAL COMMUNICATIONS, INC.
D-SRC-12-1
Not in Commercial Distribution

  • 00850016398253 ()
D-SRC-12-1

  • Nurse call system

Amplion Care Assurance - 00850016398246

Smart Light (SL), Version 1.1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-SL-11-1
Not in Commercial Distribution

  • 00850016398246 ()
D-SL-11-1

  • Nurse call system

Amplion Care Assurance - 00850016398239

Shower Station (SHS), Version 1.1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-SHS-11-1
Not in Commercial Distribution

  • 00850016398239 ()
D-SHS-11-1

  • Nurse call system

Amplion Care Assurance - 00850016398222

Patient Station (No Audio) (PASNA), Version 1.3, with No Audio
AMPLION CLINICAL COMMUNICATIONS, INC.
D-PASNA-13-1
Not in Commercial Distribution

  • 00850016398222 ()
D-PASNA-13-1

  • Nurse call system

Amplion Care Assurance - 00850016398215

Patient Station (PAS), Version 1.3
AMPLION CLINICAL COMMUNICATIONS, INC.
D-PAS-13-1
Not in Commercial Distribution

  • 00850016398215 ()
D-PAS-13-1

  • Nurse call system

Amplion Care Assurance - 00850016398208

Patient Station (PAS), Version 1.2
AMPLION CLINICAL COMMUNICATIONS, INC.
D-PAS-12-1
Not in Commercial Distribution

  • 00850016398208 ()
D-PAS-12-1

  • Nurse call system

Amplion Care Assurance - 00850016398192

Mushroom Nurse Call Button (MNC) with cable harness
AMPLION CLINICAL COMMUNICATIONS, INC.
D-MNC-X-1
Not in Commercial Distribution

  • 00850016398192 ()
D-MNC-X-1

  • Nurse call system

Amplion Care Assurance - 00850016398185

Emergency Station (ES), Version 1.0
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ES-10-1
Not in Commercial Distribution

  • 00850016398185 ()
D-ES-10-1

  • Nurse call system

Amplion Care Assurance - 00850016398178

Duty Station (DS), Version 1.1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-DS-11-1
Not in Commercial Distribution

  • 00850016398178 ()
D-DS-11-1

  • Nurse call system

Amplion Care Assurance - 00850016398161

Daughter Board (DB), Version 1.0 - Configuration 1 includes a keypad with the following features: Vent (green), Pad (yellow), BiPap (brown)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-DB-10-1
Not in Commercial Distribution

  • 00850016398161 ()
D-DB-10-1

  • Nurse call system
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