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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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ImagineMIC - B353IM11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system

Cherish Serenity - B353CS124501

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CS1245
Not in Commercial Distribution

  • B353CS124502 ()
  • B353CS124501 ()
  • B353CS124503 ()


  • Electrocardiography telemetric monitoring system

Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder

Clear Guide TipTAG - B201CGTT0

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

Clear Guide SteriMASK - B201CGSMM0

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

Nasal Alar Sp02 Sensor - B2130201A010

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

Nasal Alar Sp02 Sensor - B213301112140

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

Nasal Alar Sp02 Sensor - B21303030

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

Easy Glide 60cc Luer Lock Syringe - B2086766600

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 - B2086760600

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 - B2086733300

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 - B2086713500

Easy Glide 1cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
671350
In Commercial Distribution

  • B2086713503 ()
  • B2086713501 ()
  • B2086713500 ()


  • General-purpose syringe, single-use

Prager Ext Set B1263 - B360011B12630

Replacement Part
ESI CORPORATION
011B1263
In Commercial Distribution

  • B360011B12632 ()
  • B360011B12630 ()
  • B360011B12631 ()

  • Length: 14 Inch
011B1263

  • Basic intravenous administration set, noninvasive

Fascile Continuous Peripheral Nerve Block Set - B372500001011

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Solo-Dex, Inc
70mm, Kit with filter
Not in Commercial Distribution

  • B3723000301015 ()
  • B372500001011 ()
  • B3721001385 ()

  • Length: 70 Millimeter
500001-01

  • Peripheral nerve-block sharp needle

Perineologic - B371P10010

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

ABC Mouthpiece and Filter Kit - B365122100

No Description
Aktina Corp.
12-210
In Commercial Distribution

  • B3651120008102 ()
  • B365122100 ()
  • B3651120008011 ()


  • Pulmonary function testing kit

Dr Dennis Gross Skincare - B347BA5706100

No Description
LED TECHNOLOGIES INC
BA570610
In Commercial Distribution

  • B347BA5706101 ()
  • B347BA5706100 ()
  • B347BA5706102 ()


  • Blue/red/infrared phototherapy lamp

Dr Dennis Gross Skincare - B347BA5688100

No Description
LED TECHNOLOGIES INC
BA568810
In Commercial Distribution

  • B347BA5688101 ()
  • B347BA5688100 ()
  • B347BA5688102 ()


  • Blue/red/infrared phototherapy lamp

Dr Dennis Gross Skincare - B347BA5682100

No Description
LED TECHNOLOGIES INC
BA568210
In Commercial Distribution

  • B347BA5682101 ()
  • B347BA5682100 ()
  • B347BA5682102 ()


  • Blue/red/infrared phototherapy lamp

Dr Dennis Gross Skincare - B347BA5681100

No Description
LED TECHNOLOGIES INC
BA568110
In Commercial Distribution

  • B347BA5681101 ()
  • B347BA5681100 ()
  • B347BA5681102 ()


  • Blue/red/infrared phototherapy lamp

Drx SpotLite - B347BA5674100

No Description
LED TECHNOLOGIES INC
BA567410
In Commercial Distribution

  • B347BA5674102 ()
  • B347BA5674101 ()
  • B347BA5674100 ()


  • Blue/red/infrared phototherapy lamp

Drx SpectraLite Faceware - B347BA5672100

No Description
LED TECHNOLOGIES INC
BA567210
Not in Commercial Distribution

  • B347BA5672101 ()
  • B347BA5672100 ()
  • B347BA5672102 ()


  • Blue/red/infrared phototherapy lamp

Glo Skin Beauty - B34757560

No Description
LED TECHNOLOGIES INC
5756
Not in Commercial Distribution

  • B34757561 ()
  • B34757560 ()
  • B34757562 ()


  • Blue/red/infrared phototherapy lamp

CosmoLock Pedicle Screw System - B07311LCL00000

Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Spinal bone set screw

Oasis - B031AHS650

SURGEON GLOVES,LATEX,SIZE 6.5
American Health Service Sales Corporation
AHS-6.5
In Commercial Distribution

  • B031AHS651 ()
  • B031AHS650 ()
  • B031AHS652 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

Oasis - B031AHS60

SURGEON GLOVES,LATEX,SIZE 6
American Health Service Sales Corporation
AHS-6
In Commercial Distribution

  • B031AHS61 ()
  • B031AHS60 ()
  • B031AHS62 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

AHS - B031AHS2714RN0

NEEDLE,27G X 1 1/4"
American Health Service Sales Corporation
AHS2714RN
In Commercial Distribution

  • B031AHS2714RN01 ()
  • B031AHS2714RN0 ()
  • B031AHS2714RN02 ()


  • Hypodermic needle, single-use

AHS - B031AHS2713RN0

NEEDLE,27G X 1/2"
American Health Service Sales Corporation
AHS2713RN
In Commercial Distribution

  • B031AHS2713RN01 ()
  • B031AHS2713RN0 ()
  • B031AHS2713RN02 ()


  • Hypodermic needle, single-use

AHS - B031AH60S0

SYRINGE,60CC,LUER SLIP
American Health Service Sales Corporation
AH60S
In Commercial Distribution

  • B031AH60S2 ()
  • B031AH60S1 ()
  • B031AH60S0 ()


  • General-purpose syringe, single-use
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