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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No Description
Light Sources, Inc.
0726
In Commercial Distribution

  • G51007260 ()


  • Ultraviolet tanning device
Gutta Percha Points and Bars, Length Marked 02 taper 90/140, 120Points, P 31S
Meta Biomed Co., Ltd.
0726
In Commercial Distribution

  • 08806387807261 ()


  • Synthetic gutta-percha
Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable.
SWANN-MORTON LIMITED
X SWANN MAJOR BLADES
Not in Commercial Distribution

  • 05063043007264 ()
  • 05033955007263 ()
0726

  • Manual scalpel blade, single-use
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution

  • 00884838082137 ()
mSafe

  • Vulnerable patient home alert system
IBP interface cable/华南医电/Edwards/LP5/4.0M
Unimed Medical Supplies, Inc.
BC-HY-ED
In Commercial Distribution

  • 06945664869171 ()


  • Electrical-only medical device connection cable, reusable
Reusable SpO2 Sensor/优瑞/Wrap/Neonate/3.0M/LP6
Unimed Medical Supplies, Inc.
U310-143
In Commercial Distribution

  • 06945664812115 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/优瑞/Finger Clip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410-143
In Commercial Distribution

  • 06945664809719 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/优瑞/Y-type Multi-site/All Patient/3.0M/LP6
Unimed Medical Supplies, Inc.
U810-143
In Commercial Distribution

  • 06945664814454 ()


  • Pulse oximeter probe, reusable
Glucose Test Strip (Non-apps)
NUVOMED, INC.
NGS50-24/0726
In Commercial Distribution

  • 00859811007261 ()


  • Glucose analyser IVD, home-use
Insert trial-Fixed-Constrained-07
Corentec Co., Ltd
KB.STT.0726
In Commercial Distribution

  • 08800017284323 ()


  • Knee tibia prosthesis trial, reusable
KC 072-6, 22mm ID, 72" length - Reusable Ventilator Tubing - clear polyester elastomer tube with gray thermoplastic rubber cuffs
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 072-6
In Commercial Distribution

  • M996KC07260 ()


  • Ventilator breathing circuit, reusable
Nasal Cannula PG/PSG
SALTER LABS
70710316
In Commercial Distribution

  • 30889483610569 ()
  • 10889483610565 ()


  • Respiratory apnoea monitoring system
REUSABLE ULTRAFLOW RESPIRATION MONITOR: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
Advantage Medical Electronics, LLC
SM-603700
In Commercial Distribution

  • 00849593015615 ()


  • Patient monitoring system module, electrocardiographic/respiratory
NO CASING MULTIFLOW RESPIRATION MONITOR: SINGLE THERMOCOUPLE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL)
Advantage Medical Electronics, LLC
SM-602548
In Commercial Distribution

  • 00849593015608 ()


  • Patient monitoring system module, electrocardiographic/respiratory
DUAL NO CASING RESP. MONITOR
Advantage Medical Electronics, LLC
SM-602353
In Commercial Distribution

  • 00849593015585 ()


  • Patient monitoring system module, electrocardiographic/respiratory
RD rainbow SET RAM Dual Cable, MD20-12
MASIMO CORPORATION
4279
In Commercial Distribution

  • 00843997012539 ()


  • Electrical-only medical device connection cable, reusable
RD rainbow SET RAM Dual Cable, R25-12
MASIMO CORPORATION
4278
In Commercial Distribution

  • 00843997012522 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
4100
In Commercial Distribution

  • 00843997011648 ()


  • Electrical-only medical device connection cable, reusable
RAM Dual Cable, LNC M20-10 LNCS & RAS M20 dual patient cable 10ft./3.0m
MASIMO CORPORATION
4099
In Commercial Distribution

  • 00843997011631 ()


  • Electrical-only medical device connection cable, reusable
ThermiSense® (Pediatric) Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.
SALTER LABS
5700PCK-2-0-1
In Commercial Distribution

  • 00607411893476 ()

  • Pediatric
5700PCK-2-0-1

  • Respiratory apnoea monitoring system
ThermiSense® Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal.
SALTER LABS
5700CK-2-0
In Commercial Distribution

  • 00607411891847 ()

  • Adult
5700CK-2-0

  • Respiratory apnoea monitoring system
PneumoTherm™ Adaptor Cable "REUSABLE" 6" Wire for use with the PneumoTherm™ Thermocouple.
SALTER LABS
5811-0
In Commercial Distribution

  • 00607411889745 ()
5811

  • Respiratory apnoea monitoring system
SnoreTAC® adapter replaces the Snore Microphone when used with BiNAPS®. Use during CPAP Titration.
SALTER LABS
5531-0
In Commercial Distribution

  • 10607411801133 ()
  • 00607411801136 ()

  • Adult
5531-0

  • Respiratory apnoea monitoring system
Replaces Snore Microphone when used with BiNAPS® Snore Sensing Adapter for BiNAPS® use during CPAP Titration. SO-1990, ABM
SALTER LABS
5530-0
In Commercial Distribution

  • 00607411801105 ()
  • 10607411801102 ()
SO-1990

  • Respiratory apnoea monitoring system
Adult Nasal Pressure Monitoring Cannula with 2' (0.6 m) tube with male Luer-Lock connection.
SALTER LABS
5012-2
In Commercial Distribution

  • 10607411801065 ()
  • 00607411801068 ()

  • Adult
5012-2

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring Cannula with 2' (0.6 m) tube with male Luer-lock connection.
SALTER LABS
5006-2
In Commercial Distribution

  • 10607411500623 ()
  • 00607411500626 ()

  • Adult
5006-2

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring Cannula with 2’ (0.6 m) tube with filter.
SALTER LABS
5005-2
In Commercial Distribution

  • 10607411500616 ()
  • 00607411500619 ()

  • Adult
5005-2

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with male Luer-lock connection.
SALTER LABS
5006-7
In Commercial Distribution

  • 10607411500609 ()
  • 00607411500602 ()

  • Adult
5006-7

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring Cannula with 7’ (2.1 m) tube with filter.
SALTER LABS
5005-7
In Commercial Distribution

  • 10607411500593 ()
  • 00607411500596 ()

  • Adult
5005-7

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring & Gas Sampling Cannula with 7' (2.1 m) tubes with male/female connector for gas sampling and filter for pressure monitoring.
SALTER LABS
5047-7-7
In Commercial Distribution

  • 10607411500500 ()
  • 00607411500503 ()

  • Adult
5047-7-7

  • Respiratory apnoea monitoring system
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