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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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Mediblu - B632MDB01035

No Description
MEDIBLU MEDICAL LLC
Blu15+
In Commercial Distribution

  • B632MDB01035 ()
MDB01035

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01034

No Description
MEDIBLU MEDICAL LLC
BLU 12+
In Commercial Distribution

  • B632MDB01034 ()
MDB01034

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01028

No Description
MEDIBLU MEDICAL LLC
BLU 12
In Commercial Distribution

  • B632MDB01028 ()
MDB01028

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01007

No Description
MEDIBLU MEDICAL LLC
FM10
In Commercial Distribution

  • B632MDB01007 ()
MDB01007

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01004

No Description
MEDIBLU MEDICAL LLC
MM5
In Commercial Distribution

  • B632MDB01004 ()
MDB01004

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01002

No Description
MEDIBLU MEDICAL LLC
MM15
In Commercial Distribution

  • B632MDB01002 ()
MDB01002

  • Multiple vital physiological parameter monitoring system, clinical

Opal V2C - B628OPALV2C0

APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.
APDM, INC.
V2C
In Commercial Distribution

  • B628OPALV2C0 ()
OPALV2C

  • Kinesiology ambulatory recorder

Docking Station V2C - B628DSV2C0

APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628DSV2C0 ()
DSV2C

  • Kinesiology ambulatory recorder

Access Point V2C - B628APV2C0

APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628APV2C0 ()
APV2C

  • Kinesiology ambulatory recorder

Mediblu - B632MDB01005

No Description
MEDIBLU MEDICAL LLC
MM3
In Commercial Distribution

  • B632MDB01005 ()
MDB01005

  • Multiple vital physiological parameter monitoring system, clinical
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