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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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Premium Study Kit - B14360201141

Single use, premium study kit extra extra large.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B14360201141 ()
  • B14360201162 ()
  • B14360201152 ()
602-0114

  • Electroencephalograph

Premium Study Kit - B14360201111

Single use, premium study kit extra large.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B14360201111 ()
  • B14360201132 ()
  • B14360201122 ()
602-0111

  • Electroencephalograph

Premium Study Kit - B14360201081

Single use, premium study kit large.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B14360201081 ()
  • B14360201102 ()
  • B14360201092 ()
602-0108

  • Electroencephalograph

Premium Study Kit - B14360200791

Single use, proact premium study kit.
Cleveland Medical Devices Inc.
Proact - Single
In Commercial Distribution

  • B14360200791 ()
  • B14360200812 ()
  • B14360200802 ()
602-0079

  • Electroencephalograph

Study Kit - B14360200761

Single use study kit (compatible with thermistor).
Cleveland Medical Devices Inc.
Compatible with Thermistor - Single
In Commercial Distribution

  • B14360200761 ()
  • B14360200772 ()
  • B14360200782 ()
602-0076

  • Electroencephalograph

Study Kit - B14360200751

No Description
Cleveland Medical Devices Inc.
Single
In Commercial Distribution

  • B14360200751 ()
  • B14360200692 ()
  • B14360200682 ()
602-0075

  • Electroencephalograph

ReadyRip Belt - B143502020450

Single use, extra extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B143502020450 ()
  • B14360201051 ()
  • B14360201021 ()
502-0204-5

  • Electroencephalograph

ReadyRip Belt - B143502020440

Single use, extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B143502020440 ()
  • B14360201041 ()
  • B14360201011 ()
502-0204-4

  • Electroencephalograph

ReadyRip Belt - B143502020430

Single use, large respiratory belt.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B143502020430 ()
  • B14360201031 ()
  • B14360201001 ()
502-0204-3

  • Electroencephalograph

ReadyRip Belt - B143502020420

Single use, medium respiratory belt.
Cleveland Medical Devices Inc.
Medium - Single
In Commercial Distribution

  • B143502020420 ()
  • B14360201311 ()
  • B14360201301 ()
502-0204-2

  • Electroencephalograph

CUVETTES DC-80 Box 100 cuvettes & 100 plugs - B154O00103910003

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

Q-Lase™ Adjustable Sheath - B145115150

Q-Lase Adjustable Sheath
OPTICAL INTEGRITY INC
11515
In Commercial Distribution

  • B145115152 ()
  • B145115151 ()
  • B145115150 ()

  • Outer Diameter: 800 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable

IB-STIM - B327NSS203

The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
IB-STIM
In Commercial Distribution

  • B327NSS2032 ()
  • B327NSS203 ()
  • B327NSS2031 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

NSS MFS - B327NSS202

The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution

  • B327NSS202 ()
  • B327NSS2022 ()
  • B327NSS2021 ()
01-1011-NSS/MFS

  • Acupuncture electrical stimulation system

NSS Neurostim - B327NSS201

The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Neurostim
In Commercial Distribution

  • B327NSS201 ()
  • B327NSS2012 ()
  • B327NSS2011 ()
01-1021

  • Acupuncture electrical stimulation system

NSS-2 - B327NSS200

The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear and connected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Bridge
In Commercial Distribution

  • B327NSS200 ()
  • B327NSS2002 ()
  • B327NSS2001 ()
01-1017-NSS-2/Bridge

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

DRUGS OF ABUSE LEVEL 3 - B800DAU3V2FUVMG0

DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DAU 3 V2 F U VMG
In Commercial Distribution

  • B800DAU3V2FUVMG0 ()
  • B800DAU3V2FUVMG05 ()
  • B800DAU3V2FUVMG5 ()

  • Total Volume: 10 Milliliter
DAU 3 V2 F U VMG

  • Multiple drugs of abuse IVD, control

BUSULFAN 25 NG/ML - B800BUS25VPFCHLA0

BUSULFAN 25 NG/ML
UTAK LABORATORIES, INC.
BUS 25 V P F CHLA
In Commercial Distribution

  • B800BUS25VPFCHLA5 ()
  • B800BUS25VPFCHLA0 ()
  • B800BUS25VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 25 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control

BUS 250 V P F CHLA - B800BUS250VPFCHLA0

BUS 250 V P F CHLA
UTAK LABORATORIES, INC.
BUS 250 V P F CHLA
In Commercial Distribution

  • B800BUS250VPFCHLA5 ()
  • B800BUS250VPFCHLA0 ()
  • B800BUS250VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 250 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control

BUSULFAN 10 NG/ML - B800BUS10VPFCHLA0

BUSULFAN 10 NG/ML
UTAK LABORATORIES, INC.
BUS 10 V P F CHLA
In Commercial Distribution

  • B800BUS10VPFCHLA5 ()
  • B800BUS10VPFCHLA0 ()
  • B800BUS10VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 10 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control

BUSULFAN 100 NG/ML - B800BUS100VPFCHLA0

BUSULFAN 100 NG/ML
UTAK LABORATORIES, INC.
BUS 100 V P F CHLA
In Commercial Distribution

  • B800BUS100VPFCHLA5 ()
  • B800BUS100VPFCHLA0 ()
  • B800BUS100VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 100 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control

BUSULFAN 1000 NG/ML - B800BUS1000VPFCHLA0

BUSULFAN 1000 NG/ML
UTAK LABORATORIES, INC.
BUS 1000 V P F CHLA
In Commercial Distribution

  • B800BUS1000VPFCHLA5 ()
  • B800BUS1000VPFCHLA0 ()
  • B800BUS1000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 1000 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control

ACETONE BLANK - B800ACEBLKSFBSRHS0

ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control

Soviflex - B79510010

Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor

SPEAX Patch - B792FGN002

Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system

OLO CBC Test Kit - B787TK10

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
In Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count

Health Team - M368HT18571

Digital Thermometer
GF HEALTH PRODUCTS, INC.
HT1857
In Commercial Distribution

  • M368HT18573 ()
  • M368HT18572 ()
  • M368HT18571 ()


  • Intermittent electronic patient thermometer

Grafco - M368GFTX5EMS1

Digital EMS TENS Unit
GF HEALTH PRODUCTS, INC.
GF-TX5EMS
In Commercial Distribution

  • M368GFTX5EMS3 ()
  • M368GFTX5EMS2 ()
  • M368GFTX5EMS1 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GFTX51

Digital TENS Unit
GF HEALTH PRODUCTS, INC.
GF-TX5
In Commercial Distribution

  • M368GFTX53 ()
  • M368GFTX52 ()
  • M368GFTX51 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GF451

Digital TENS Lead Wires
GF HEALTH PRODUCTS, INC.
GF-45
In Commercial Distribution

  • M368GF453 ()
  • M368GF452 ()
  • M368GF451 ()


  • Transcutaneous electrical stimulation lead

Grafco - M368GF3T1

TENS Unit, Analog
GF HEALTH PRODUCTS, INC.
GF-3T
In Commercial Distribution

  • M368GF3T3 ()
  • M368GF3T2 ()
  • M368GF3T1 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GF31

TENS Unit, Analog
GF HEALTH PRODUCTS, INC.
GF-3
In Commercial Distribution

  • M368GF33 ()
  • M368GF32 ()
  • M368GF31 ()


  • Analgesic transcutaneous electrical nerve stimulation system

LUMISCOPE - M368L22141

Flexible Tip Digital Thermometer
GF HEALTH PRODUCTS, INC.
L2214
In Commercial Distribution

  • M368L22143 ()
  • M368L22142 ()
  • M368L22141 ()


  • Intermittent electronic patient thermometer

LUMISCOPE - M368L20131

Jumbo Display Digital Thermometer
GF HEALTH PRODUCTS, INC.
L2013
In Commercial Distribution

  • M368L20133 ()
  • M368L20132 ()
  • M368L20131 ()


  • Intermittent electronic patient thermometer

CUSTOMED - M208CUS160

SUCTION CATHETER 16FR
CUSTOMED INC
152570148316
In Commercial Distribution

  • M208CUS160 ()
  • M208CUS161 ()
  • M208CUS162 ()

  • 16 FR
CUS16

  • Airway suction catheter

CUSTOMED - M208CUS140

SUCTION CATHETER 14FR
CUSTOMED INC
152570148314
In Commercial Distribution

  • M208CUS140 ()
  • M208CUS141 ()
  • M208CUS142 ()

  • 14 FR
CUS14

  • Airway suction catheter

CUSTOMED - M208CUS100

SUCTION CATHETER 10FR
CUSTOMED INC
152570148310
In Commercial Distribution

  • M208CUS100 ()
  • M208CUS101 ()
  • M208CUS102 ()

  • 10 FR
CUS10

  • Airway suction catheter

CUSTOMED - M208CUS080

SUCTION CATHETER 8FR
CUSTOMED INC
152570148308
In Commercial Distribution

  • M208CUS080 ()
  • M208CUS081 ()
  • M208CUS082 ()

  • 8 FR
CUS08

  • Airway suction catheter

CUSTOMED - M20890030517

CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 8
CUSTOMED INC
712057693051
In Commercial Distribution

  • M20890030517 ()
  • M20890030510 ()
  • M20890030511 ()
  • M20890030512 ()

  • Circumference: 8.0 Inch
9003051

  • Hevea-latex surgical glove, powdered

CUSTOMED - M20890030497

CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 7
CUSTOMED INC
712057693049
In Commercial Distribution

  • M20890030497 ()
  • M20890030490 ()
  • M20890030491 ()
  • M20890030492 ()

  • Circumference: 7.0 Inch
9003049

  • Hevea-latex surgical glove, powdered

CUSTOMED - M20890030160

ENDOTRACHEAL TUBE, CUFFED, SIZE: 10.0MM
CUSTOMED INC
712057143016
In Commercial Distribution

  • M20890030160 ()
  • M20890030161 ()
  • M20890030162 ()

  • Lumen/Inner Diameter: 10.0 Millimeter
9003016

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030150

ENDOTRACHEAL TUBE, CUFFED, SIZE: 9.0MM
CUSTOMED INC
712057143015
In Commercial Distribution

  • M20890030150 ()
  • M20890030151 ()
  • M20890030152 ()

  • Lumen/Inner Diameter: 9.0 Millimeter
9003015

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030120

ENDOTRACHEAL TUBE, CUFFED, SIZE: 7.5MM
CUSTOMED INC
712057143012
In Commercial Distribution

  • M20890030120 ()
  • M20890030121 ()
  • M20890030122 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
9003012

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030090

ENDOTRACHEAL TUBE, CUFFED, SIZE: 6.0MM
CUSTOMED INC
712057143009
In Commercial Distribution

  • M20890030090 ()
  • M20890030091 ()
  • M20890030092 ()

  • Lumen/Inner Diameter: 6.0 Millimeter
9003009

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030050

ENDOTRACHEAL TUBE UNCUFFED, SIZE: 5.0MM
CUSTOMED INC
712057143005
In Commercial Distribution

  • M20890030050 ()
  • M20890030051 ()
  • M20890030052 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
9003005

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030030

ENDOTRACHEAL TUBE UNCUFFED, SIZE: 4.0MM
CUSTOMED INC
712057143003
In Commercial Distribution

  • M20890030030 ()
  • M20890030031 ()
  • M20890030032 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
9003003

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030020

ENDOTRACHEAL TUBE UNCUFFED, SIZE: 3.5MM
CUSTOMED INC
712057143002
In Commercial Distribution

  • M20890030022 ()
  • M20890030021 ()
  • M20890030020 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
9003002

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030010

ENDOTRACHEAL TUBE UNCUFFED, SIZE: 3.0MM
CUSTOMED INC
712057143001
In Commercial Distribution

  • M20890030010 ()
  • M20890030011 ()
  • M20890030012 ()

  • Lumen/Inner Diameter: 3.0 Millimeter
9003001

  • Basic endotracheal tube, single-use

CUSTOMED - M20890030000

ENDOTRACHEAL TUBE UNCUFFED, SIZE: 2.5MM
CUSTOMED INC
712057143000
In Commercial Distribution

  • M20890030000 ()
  • M20890030001 ()
  • M20890030002 ()

  • Lumen/Inner Diameter: 2.5 Millimeter
9003000

  • Basic endotracheal tube, single-use

CUSTOMED - M20890029990

ENDOTRACHEAL TUBE UNCUFFED, SIZE: 2.0MM
CUSTOMED INC
712057142999
In Commercial Distribution

  • M20890029991 ()
  • M20890029990 ()
  • M20890029992 ()

  • Lumen/Inner Diameter: 2.0 Millimeter
9002999

  • Basic endotracheal tube, single-use
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