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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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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
MAGILL Intubation forceps, Intubation aid, made of stainless steel, single use, size infant, box of 10 pcs, length 6.75” (17 cm)
Carnegie Surgical LLC
304-084
In Commercial Distribution

  • G1413040841 ()
  • G1413040840 ()
  • G1413040842 ()
304-084

  • Airway tube forceps, single-use
MAGILL Intubation forceps, Intubation aid, made of stainless steel, single use, size child, box of 10 pcs, length 8”/20 cm
Carnegie Surgical LLC
304-082
In Commercial Distribution

  • G1413040821 ()
  • G1413040820 ()
  • G1413040822 ()
304-082

  • Airway tube forceps, single-use
MAGILL Intubation forceps, Intubation aid, made of stainless steel, single use, size adult, box of 10 pcs, length 9.5” (24 cm)
Carnegie Surgical LLC
304-080
In Commercial Distribution

  • G1413040801 ()
  • G1413040800 ()
  • G1413040802 ()
304-080

  • Airway tube forceps, single-use
Permanent Tissue-Integrating Surgical Matrix
CORNEAT VISION LTD
1007691
In Commercial Distribution

  • G16010362951 ()
  • G16010362950 ()
  • G16010362952 ()

  • 5.0 mm X 6.5 mm X 100 um
1036295

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Flexible tip laryngoscope blade fig 1, straight, green system, single patient use, non-sterile, metal flap, working length 2 7/8” (72 mm) (Pack of 5)
Carnegie Surgical LLC
404-8051
In Commercial Distribution

  • G14140480511 ()
  • G14140480510 ()
  • G14140480512 ()
404-8051

  • Laryngoscope blade, single-use
Flexible tip laryngoscope blade fig 0, straight, green system, single patient use, non-sterile, metal flap, working length 2 1/2” (62 mm) (Pack of 5)
Carnegie Surgical LLC
404-8050
In Commercial Distribution

  • G14140480501 ()
  • G14140480500 ()
  • G14140480502 ()
404-8050

  • Laryngoscope blade, single-use
Flexible tip laryngoscope blade fig 4, curved, conventional, with LED, single patient use, non-sterile, metal flap, working length 5 1/2” (139 mm) (Pack of 5)
Carnegie Surgical LLC
404-8044
In Commercial Distribution

  • G14140480441 ()
  • G14140480440 ()
  • G14140480442 ()
404-8044

  • Laryngoscope blade, single-use
Flexible tip laryngoscope blade fig 3, curved, conventional, with LED, single patient use, non-sterile, metal flap, working length 4 1/2” (116 mm) (Pack of 5)
Carnegie Surgical LLC
404-8043
In Commercial Distribution

  • G14140480431 ()
  • G14140480430 ()
  • G14140480432 ()
404-8043

  • Laryngoscope blade, single-use
Flexible tip laryngoscope blade fig 4, curved, green system, single patient use, non-sterile, metal flap, working length 5 3/8” (137 mm) (Pack of 5)
Carnegie Surgical LLC
404-8034
In Commercial Distribution

  • G14140480341 ()
  • G14140480340 ()
  • G14140480342 ()
404-8034

  • Laryngoscope blade, single-use
Flexible tip laryngoscope blade fig 3, curved, green system, single patient use, non-sterile, metal flap, working length 4 3/8” (110 mm) (Pack of 5)
Carnegie Surgical LLC
404-8033
In Commercial Distribution

  • G14140480331 ()
  • G14140480330 ()
  • G14140480332 ()
404-8033

  • Laryngoscope blade, single-use
MILLER Laryngoscope blade fig 00, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (44 mm) (pack of 10)
Carnegie Surgical LLC
404-7697
In Commercial Distribution

  • G14140476971 ()
  • G14140476970 ()
  • G14140476972 ()
404-7697

  • Rigid intubation laryngoscope, single-use
MILLER Laryngoscope blade fig 4, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (182 mm) (pack of 10)
Carnegie Surgical LLC
404-7648
In Commercial Distribution

  • G14140476481 ()
  • G14140476480 ()
  • G14140476482 ()
404-7648

  • Rigid intubation laryngoscope, single-use
MILLER Laryngoscope blade fig 3, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (175 mm) (pack of 10)
Carnegie Surgical LLC
404-7638
In Commercial Distribution

  • G14140476381 ()
  • G14140476380 ()
  • G14140476382 ()
404-7638

  • Rigid intubation laryngoscope, single-use
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