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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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Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.
WATERS MEDICAL SYSTEMS, LLC
Cuvette/Plug Kit
In Commercial Distribution

  • B154O00103910003 ()
  • 0034791000 ()
  • 0033991000 ()
0010391.000

  • Intracardiac oximeter
The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
301-11214
In Commercial Distribution

  • B213301112140 ()
  • B213301112141 ()
  • B213301112142 ()


  • Pulse oximeter probe, single-use
The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
0303
In Commercial Distribution

  • B21303031 ()
  • B21303030 ()
  • B21303032 ()


  • Pulse oximeter probe, single-use
The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor (REF 0201-A01) is for use with Philips FAST SpO2 compatible monitors.
XHALE ASSURANCE, INC.
0201-A01
In Commercial Distribution

  • B2130201A012 ()
  • B2130201A011 ()
  • B2130201A010 ()


  • Pulse oximeter probe, single-use
No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use
The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet.
CLEAR GUIDE MEDICAL, INC.
CGSMM
In Commercial Distribution

  • B201CGSMM0 ()
  • B201CGSMM1 ()
  • B201CGSMM2 ()
CG-SM-M

  • Optical medical device procedural cover
  • Intraoperative ultrasound imaging transducer cover
Disposable Bipolar Cord Straight 12 FT
STINGRAY SURGICAL PRODUCTS L.L.C.
S04-800
Not in Commercial Distribution

  • B112S048000 ()
  • B112S048001 ()
  • B112S048002 ()


  • Electrical-only medical device connection cable, single-use
Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9394
In Commercial Distribution

  • B13093941 ()
  • B13093942 ()
  • B13093943 ()


  • Nerve-locating system
Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9094
In Commercial Distribution

  • B13090941 ()
  • B13090942 ()
  • B13090943 ()


  • Nerve-locating system
No Description
MEDITECH SPINE, LLC
S1-7-42141-14
In Commercial Distribution

  • B167S2742141141 ()
  • B167S4742141142 ()
  • B167S1742141140 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-42141-12
In Commercial Distribution

  • B167S2742141121 ()
  • B167S4742141122 ()
  • B167S1742141120 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-20
In Commercial Distribution

  • B167S2741141201 ()
  • B167S4741141202 ()
  • B167S1741141200 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-16
In Commercial Distribution

  • B167S2741141161 ()
  • B167S4741141162 ()
  • B167S1741141160 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-7-41141-12
In Commercial Distribution

  • B167S4741141122 ()
  • B167S2741141121 ()
  • B167S1741141120 ()


  • Spinal bone screw, non-bioabsorbable
Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000X12
In Commercial Distribution

  • B467BP4512 ()
  • B467BP5612T1 ()
  • B467BP4512T3 ()
BP6/7

  • Haemodialysis concentrate
Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000X10
In Commercial Distribution

  • B467BP4510 ()
  • B467BP4510T1 ()
  • B467BP4510T3 ()
BP4/5

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36235-10200
In Commercial Distribution

  • B467ACP362351020025 ()
  • B467ACP3623510200 ()
  • B467ACP362351020033 ()
ACP4

  • Haemodialysis concentrate
Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
80025-10200
In Commercial Distribution

  • B467800251020055 ()
  • B4678002510200 ()
  • B46780025102004 ()
ACD36-ACG78

  • Haemodialysis concentrate
Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
80020-10200
In Commercial Distribution

  • B467800201020055 ()
  • B4678002010200 ()
  • B46780020102004 ()
ACG77

  • Haemodialysis concentrate
Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
80000-10200
In Commercial Distribution

  • B467800001020055 ()
  • B4678000010200 ()
  • B46780000102004 ()
ACG76

  • Haemodialysis concentrate
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