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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Connor Series Baby Bassinet, Stainless Steel Construction, rust-resistant
Amico Patient Care Corporation
CONNOR SERIES
In Commercial Distribution

  • 07540200000354 ()


  • Neonatal bed
Marco Series Baby Bassinet, High pressure laminate, melamine, wood/veneer or seamless thermofoil finish
Amico Patient Care Corporation
MARCO SERIES
In Commercial Distribution

  • 07540200000347 ()


  • Neonatal bed
Ava Series Baby Bassinet, High pressure laminate, melamine, wood/veneer or seamless thermofoil finish
Amico Patient Care Corporation
AVA SERIES
In Commercial Distribution

  • 07540200000330 ()


  • Neonatal bed
SENTINEL VACUUM REGULATOR, DIGITAL, NEO INTERMITTENT, 0 - 100MMHG
Amico Patient Care Corporation
SSD-NI
In Commercial Distribution

  • 07540200000323 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, NEO INTERMITTENT, 0 - 100MMHG
Amico Patient Care Corporation
SSA-NI
In Commercial Distribution

  • 07540200000316 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, DIGITAL, PED INTERMITTENT, 0 - 160MMHG
Amico Patient Care Corporation
SSD-PI
In Commercial Distribution

  • 07540200000309 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, PED INTERMITTENT, 0 - 160MMHG
Amico Patient Care Corporation
SSA-PI
In Commercial Distribution

  • 07540200000293 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, DIGITAL, NEO 2 MODE, 0 - 100MMHG
Amico Patient Care Corporation
SSD-N2
In Commercial Distribution

  • 07540200000286 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, NEO 2 MODE, 0 - 100MMHG
Amico Patient Care Corporation
SSA-N2
In Commercial Distribution

  • 07540200000279 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, DIGITAL, PED 2 MODE, 0 - 160MMHG
Amico Patient Care Corporation
SSD-P2
In Commercial Distribution

  • 07540200000262 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, PED 2 MODE, 0 - 160MMHG
Amico Patient Care Corporation
SSA-P2
In Commercial Distribution

  • 07540200000255 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, DIGITAL, INTERMITTENT, 0 - 300MMHG
Amico Patient Care Corporation
SSD-CI
In Commercial Distribution

  • 07540200000248 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, INTERMITTENT, 0 - 300MMHG
Amico Patient Care Corporation
SSA-CI
In Commercial Distribution

  • 07540200000231 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, DIGITAL, HIGH MODE, 0 - 750MMHG
Amico Patient Care Corporation
SSD-CH
In Commercial Distribution

  • 07540200000224 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, HIGH MODE, 0 - 750MMHG
Amico Patient Care Corporation
SSA-CH
In Commercial Distribution

  • 07540200000217 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, DIGITAL, 3 MODE, 0 - 300MMHG
Amico Patient Care Corporation
SSD-C3
In Commercial Distribution

  • 07540200000200 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, 3 MODE, 0 - 300MMHG
Amico Patient Care Corporation
SSA-C3
In Commercial Distribution

  • 07540200000194 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, DIGITAL, 2 MODE, 0 - 300MMHG
Amico Patient Care Corporation
SSD-C2
In Commercial Distribution

  • 07540200000187 ()


  • General-purpose suction system, vacuum
SENTINEL VACUUM REGULATOR, ANALOG, 2 MODE, 0 - 300MMHG
Amico Patient Care Corporation
SSA-C2
In Commercial Distribution

  • 07540200000170 ()


  • General-purpose suction system, vacuum
SCOUT VACUUM REGULATOR, DIGITAL, NEO INTERMITTENT, 0 - 100MMHG
Amico Patient Care Corporation
SRD-NI
In Commercial Distribution

  • 07540200000163 ()


  • General-purpose suction system, vacuum
No Description
Remote Patient Devices LLC
HH-XIII-T
In Commercial Distribution

  • 00860004687580 ()


  • Manual blood lancing device, reusable
No Description
Remote Patient Devices LLC
I
In Commercial Distribution

  • 00860004687573 ()


  • Blood lancet, single-use
No Description
Remote Patient Devices LLC
TCS01
In Commercial Distribution

  • 00860004687566 ()


  • Glucose IVD, kit, electrometry
No Description
Remote Patient Devices LLC
TTS01
In Commercial Distribution

  • 00860004687559 ()


  • Blood glucose/blood pressure monitoring system, home-use
No Description
Remote Patient Devices LLC
RPD-3520G
In Commercial Distribution

  • 00860004687542 ()


  • Blood glucose/blood pressure monitoring system, home-use
No Description
Remote Patient Devices LLC
RPD-3520G
In Commercial Distribution

  • 00860004687535 ()


  • Blood glucose/blood pressure monitoring system, home-use
No Description
Remote Patient Devices LLC
RPD-3250
In Commercial Distribution

  • 00860004687528 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Self-Recovery device to assist a fallen person moving themselves to a seated position after a non-injurious fall. Color: Sea Salt
Safe Patient Solutions, L.L.C.
Sea Salt
In Commercial Distribution

  • 00860003643136 ()


  • Mobile patient lifting system, manual
Self-Recovery device to assist a fallen person moving themselves to a seated position after a non-injurious fall. Color: Graystone
Safe Patient Solutions, L.L.C.
Graystone
In Commercial Distribution

  • 00860003643129 ()


  • Mobile patient lifting system, manual
Self-Recovery device to assist a fallen person moving themselves to a seated position after a non-injurious fall. Color: Safari Brown
Safe Patient Solutions, L.L.C.
Safari Brown
In Commercial Distribution

  • 00860003643112 ()


  • Mobile patient lifting system, manual
Self-Recovery device to assist a fallen person moving themselves to a seated position after a non-injurious fall. Color: Midnight
Safe Patient Solutions, L.L.C.
Midnight
In Commercial Distribution

  • 00860003643105 ()


  • Mobile patient lifting system, manual
No Description
PATIENT POSITIONING SYSTEMS, LLC
US Version
In Commercial Distribution

  • 00860010693179 ()


  • Alternating-pressure inflator
No Description
PATIENT POSITIONING SYSTEMS, LLC
SPU Bariatric
In Commercial Distribution

  • 00860010693155 ()


  • Inflatable patient transfer sliding mattress, single-use
No Description
PATIENT POSITIONING SYSTEMS, LLC
SPU Large
In Commercial Distribution

  • 00860010693148 ()


  • Inflatable patient transfer sliding mattress, single-use
Regular
PATIENT POSITIONING SYSTEMS, LLC
SPU Regular
In Commercial Distribution

  • 00860010693131 ()


  • Inflatable patient transfer sliding mattress, single-use
No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Bariatric
In Commercial Distribution

  • 00860010693124 ()


  • Inflatable patient transfer sliding mattress, reusable
No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Large
In Commercial Distribution

  • 00860010693117 ()


  • Inflatable patient transfer sliding mattress, reusable
Regular
PATIENT POSITIONING SYSTEMS, LLC
Reusable Regular
In Commercial Distribution

  • 00860010693100 ()


  • Inflatable patient transfer sliding mattress, reusable
The holster device provides safe and convenient storage of the Yankauer Suction Tip between suctions of the individual patient. It is designed to avoid contamination of the individual patient's suction tip by preventing contact of the tip with any surface other than the patient's own disposable holster or cross contamination of other patients and healthcare personnel. The device is a disposable, plastic, wide mouthed receptacle, intended to be attached to the patient's bed rail.
PATIENT SHIELD CONCEPTS, LLC
PSC5300
In Commercial Distribution

  • 00861283000312 ()
  • 00086128000312 ()


  • Airway suction catheter
The holster device provides safe and convenient storage of the Yankauer Suction Tip between suctions of the individual patient. It is designed to avoid contamination of the individual patient's suction tip by preventing contact of the tip with any surface other than the patient's own disposable holster or cross contamination of other patients and healthcare personnel. The device is a disposable, plastic, wide mouthed receptacle, intended to be attached to the patient's bed rail.
PATIENT SHIELD CONCEPTS, LLC
PSC5300
In Commercial Distribution

  • 00861283000305 ()


  • Airway suction catheter
Dual Foot & Ankle Infrared Phototherapy System
HEALTHLIGHT LLC
HL-PB2-S
In Commercial Distribution

  • 00858935006228 ()
502029

  • Musculoskeletal infrared phototherapy unit, non-wearable
Russell Distribution Headband Infrared Phototherapy System
HEALTHLIGHT LLC
RD-HB-S
In Commercial Distribution

  • 00858935006129 ()
502020

  • Musculoskeletal infrared phototherapy unit, non-wearable
Six Port Controller, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-C6
In Commercial Distribution

  • 00858935006099 ()
502009, 502038, 502051

  • Musculoskeletal infrared phototherapy unit, non-wearable
Three Port Controller, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-C3
In Commercial Distribution

  • 00858935006082 ()
502008, 502039, 502050

  • Musculoskeletal infrared phototherapy unit, non-wearable
264 LED Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-264R
In Commercial Distribution

  • 00858935006044 ()
502004

  • Musculoskeletal infrared phototherapy unit, non-wearable
180 LED Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-180R
In Commercial Distribution

  • 00858935006037 ()
502003

  • Musculoskeletal infrared phototherapy unit, non-wearable
132 LED Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-132R
In Commercial Distribution

  • 00858935006020 ()
502002

  • Musculoskeletal infrared phototherapy unit, non-wearable
90 LED Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-90R
In Commercial Distribution

  • 00858935006013 ()
502001

  • Musculoskeletal infrared phototherapy unit, non-wearable
Infrared Heated Elbow Wrap (L/XL)
MATSUM INC
KB171260 L/XL
In Commercial Distribution

  • 00876594009701 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Back Wrap (L/XL)
MATSUM INC
KB171290 L/XL
In Commercial Distribution

  • 00876594009688 ()


  • External electric-heating core temperature regulation system pad
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