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No Description
LED TECHNOLOGIES INC
RVGLOAC
In Commercial Distribution
- B347RVGLOAC1 ()
- B347RVGLOAC0 ()
- B347RVGLOAC2 ()
- Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568810
In Commercial Distribution
- B347BA5688101 ()
- B347BA5688100 ()
- B347BA5688102 ()
- Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568110
In Commercial Distribution
- B347BA5681101 ()
- B347BA5681100 ()
- B347BA5681102 ()
- Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567210
Not in Commercial Distribution
- B347BA5672101 ()
- B347BA5672100 ()
- B347BA5672102 ()
- Blue/red/infrared phototherapy lamp
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
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
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
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
The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance.
Corbin Clinical Resources, LLC
1
In Commercial Distribution
- B371P10010 ()
- B371P10012 ()
- B371P10014 ()
- Needle guide, single-use
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution
- B353MM12501 ()
- B353MM12502 ()
- B353MM12503 ()
- Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution
- B353MA12512 ()
- B353MA12511 ()
- B353MA12513 ()
MA1251_US
- Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1253
In Commercial Distribution
- B353LP12532 ()
- B353LP12531 ()
- B353LP12533 ()
LP1253_US
- Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution
- B353LP12502 ()
- B353LP12501 ()
- B353LP12503 ()
- Electrocardiographic ambulatory recorder
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution
- B353LP11103 ()
- B353LP11102 ()
- B353LP11101 ()
- Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1210
Not in Commercial Distribution
- B353IM12103 ()
- B353IM12102 ()
- B353IM12101 ()
- Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution
- B353IM11103 ()
- B353IM11102 ()
- B353IM11101 ()
- Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
CV1253
In Commercial Distribution
- B353CV12532 ()
- B353CV12531 ()
- B353CV12533 ()
CV1253_US
- Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution
- B353CV12452 ()
- B353CV12451 ()
- B353CV12453 ()
- Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CS1245
Not in Commercial Distribution
- B353CS124502 ()
- B353CS124501 ()
- B353CS124503 ()
- Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution
- B353AB12572 ()
- B353AB12571 ()
- B353AB12573 ()
AB1257_US
- Electrocardiographic ambulatory recorder
Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution
- B353AB12512 ()
- B353AB12511 ()
- B353AB12513 ()
AB1251_US
- Electrocardiographic ambulatory recorder
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
Easy Glide 60cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
676660
In Commercial Distribution
- B2086766600 ()
- B2086766601 ()
- B2086766603 ()
- General-purpose syringe, single-use
Easy Glide 60cc Cath Tip Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
676060
In Commercial Distribution
- B2086760603 ()
- B2086760601 ()
- B2086760600 ()
- General-purpose syringe, single-use
Easy Glide 30cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
673330
In Commercial Distribution
- B2086733303 ()
- B2086733301 ()
- B2086733300 ()
- General-purpose syringe, single-use
Easy Glide 1cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
671350
In Commercial Distribution
- B2086713503 ()
- B2086713501 ()
- B2086713500 ()
- General-purpose syringe, 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