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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SPU SmartVest® – Adult Small
ELECTROMED, INC.
I-VAS-36
In Commercial Distribution

  • B102060171S0400 ()
I-VAS-36

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest® – Child Large
ELECTROMED, INC.
I-VCL-32
In Commercial Distribution

  • B102060171S0300 ()
I-VCL-32

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest® – Child Medium
ELECTROMED, INC.
I-VCM-28
In Commercial Distribution

  • B102060171S0200 ()
I-VCM-28

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest® – Child Small
ELECTROMED, INC.
I-VCS-24
In Commercial Distribution

  • B102060171S0100 ()
I-VCS-24

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest® – Child S-Small
ELECTROMED, INC.
I-VSS-20
In Commercial Distribution

  • B102060171S0050 ()
I-VSS-20

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – XX-Large
ELECTROMED, INC.
SW-54/66-1
In Commercial Distribution

  • B102060145S0800 ()
SW-54/66-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – X-Large
ELECTROMED, INC.
SW-44/54-1
In Commercial Distribution

  • B102060145S0700 ()
  • B102060154S0705 ()
SW-44/54-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – Large
ELECTROMED, INC.
SW-36/44-1
In Commercial Distribution

  • B102060145S0600 ()
  • B102060154S0605 ()
SW-36/44-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – Medium
ELECTROMED, INC.
SW-30/36-1
In Commercial Distribution

  • B102060145S0500 ()
  • B102060154S0505 ()
SW-30/36-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – Small
ELECTROMED, INC.
SW-25/30-1
In Commercial Distribution

  • B102060145S0400 ()
  • B102060154S0405 ()
SW-25/30-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – S-Small
ELECTROMED, INC.
SW-17/25-1
In Commercial Distribution

  • B102060145S0300 ()
  • B102060154S0305 ()
SW-17/25-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – S-Small
ELECTROMED, INC.
SW-15/25-1
In Commercial Distribution

  • B102060145S0200 ()
SW-15/25-1

  • Chest-oscillation airway secretion-clearing system vest
MASK,TRACH,PED,CURAPLEX,SPU
BOUND TREE MEDICAL, LLC
301-183
In Commercial Distribution

  • 00810071630873 ()
  • 00810071631276 ()
301-183

  • Tracheostomy mask, oxygen
SPU Cuff, 2 Tube,Large Adult
AMERICAN DIAGNOSTIC CORP
8400X-10
Not in Commercial Distribution

  • 00634782850166 ()
  • 00634782050368 ()

  • Large Adult, 31-40cm
8400X-10

  • Blood pressure cuff, reusable
ADTEMP I SPU Digital,Thermometer Kit
AMERICAN DIAGNOSTIC CORP
412K
In Commercial Distribution

  • 00634782548339 ()
  • 00634782848330 ()
  • 00634782048556 ()
412K

  • Intermittent electronic patient thermometer
PROSCOPE SPU Infant Scope,31", Black
AMERICAN DIAGNOSTIC CORP
676BKH
In Commercial Distribution

  • 00634782525019 ()
  • 00634782825010 ()
  • 00634782025090 ()
676BKH

  • Mechanical external stethoscope
PROSCOPE SPU Pediatric Scope,31.5", Black
AMERICAN DIAGNOSTIC CORP
675BKH
In Commercial Distribution

  • 00634782524715 ()
  • 00634782824716 ()
  • 00634782024796 ()
675BKH

  • Mechanical external stethoscope
PROSCOPE SPU Dualhead Scope,32.25", Yellow
AMERICAN DIAGNOSTIC CORP
670YH
In Commercial Distribution

  • 00634782524678 ()
  • 00634782824679 ()
  • 00634782024758 ()
670YH

  • Mechanical external stethoscope
PROSCOPE SPU Dualhead Scope,32.25", Royal
AMERICAN DIAGNOSTIC CORP
670RBH
In Commercial Distribution

  • 00634782824624 ()
  • 00634782024703 ()
670RBH

  • Mechanical external stethoscope
PROSCOPE SPU Dualhead Scope,32.25", Red
AMERICAN DIAGNOSTIC CORP
670RH
In Commercial Distribution

  • 00634782824617 ()
  • 00634782024697 ()
  • 00634782524616 ()
670RH

  • Mechanical external stethoscope
PROSCOPE SPU Dualhead Scope,32.25", Gray
AMERICAN DIAGNOSTIC CORP
670GH
In Commercial Distribution

  • 00634782824440 ()
  • 00634782024529 ()
  • 00634782524449 ()
670GH

  • Mechanical external stethoscope
PROSCOPE SPU Dualhead Scope,32.25", Black
AMERICAN DIAGNOSTIC CORP
670BKH
In Commercial Distribution

  • 00634782524418 ()
  • 00634782824419 ()
  • 00634782024499 ()
670BKH

  • Mechanical external stethoscope
PROSCOPE SPU Nurse Scope,31.5", Yellow
AMERICAN DIAGNOSTIC CORP
660YH
In Commercial Distribution

  • 00634782824365 ()
  • 00634782024444 ()
660YH

  • Mechanical external stethoscope
PROSCOPE SPU Nurse Scope,31.5", Red
AMERICAN DIAGNOSTIC CORP
660RH
In Commercial Distribution

  • 00634782824303 ()
  • 00634782024383 ()
  • 00634782524302 ()
660RH

  • Mechanical external stethoscope
PROSCOPE SPU Nurse Scope,31.5", Gray
AMERICAN DIAGNOSTIC CORP
660GH
In Commercial Distribution

  • 00634782524135 ()
  • 00634782824136 ()
  • 00634782024215 ()
660GH

  • Mechanical external stethoscope
PROSCOPE SPU Nurse Scope,31.5", Black
AMERICAN DIAGNOSTIC CORP
660BKH
In Commercial Distribution

  • 00634782524104 ()
  • 00634782824105 ()
  • 00634782024185 ()
660BKH

  • Mechanical external stethoscope
PROSCOPE SPU Dualhead Scope,32.25", Royal
AMERICAN DIAGNOSTIC CORP
670RBH
In Commercial Distribution

  • 00634782524623 ()
  • 00634782024703 ()
670RBH

  • Mechanical external stethoscope
PROSCOPE SPU Nurse Scope,31.5", Yellow
AMERICAN DIAGNOSTIC CORP
660YH
In Commercial Distribution

  • 00634782524364 ()
  • 00634782024444 ()
660YH

  • Mechanical external stethoscope
Thermal Cap, Universal Size, SPU, 1-ct
Dignitana AB
800-1104
In Commercial Distribution

  • 00850036106234 ()
800-1104

  • Scalp cooling system, hair loss
Cooling Wrap, Small Size, SPU, 1-ct
Dignitana AB
800-1103
In Commercial Distribution

  • 00850036106210 ()
800-1103

  • Scalp cooling system, hair loss
Patient Circuit, W/ PEEP, 22mm, SPU
VYAIRE MEDICAL, INC.
10820x10
In Commercial Distribution

  • 50190752117851 ()
  • 10190752117853 ()
10820x10

  • Ventilator breathing circuit, single-use
Patient Circuit W/ PEEP, 22mm, SPU
VYAIRE MEDICAL, INC.
29715-001
In Commercial Distribution

  • 50190752116120 ()
  • 10190752116122 ()
29715-001

  • Ventilator breathing circuit, single-use
Patient Circuit, W/ PEEP, 15mm, SPU
VYAIRE MEDICAL, INC.
11872x10
In Commercial Distribution

  • 50190752115192 ()
  • 10190752115194 ()
11872x10

  • Ventilator breathing circuit, single-use
Patient Circuit, W/ PEEP, 15mm, SPU
VYAIRE MEDICAL, INC.
10821x10
In Commercial Distribution

  • 50190752117868 ()
  • 10190752117860 ()
10821x10

  • Ventilator breathing circuit, single-use
Patient Circuit W/ PEEP, 15mm, SPU
VYAIRE MEDICAL, INC.
29710-001
In Commercial Distribution

  • 50190752116113 ()
  • 10190752116115 ()
29710-001

  • Ventilator breathing circuit, single-use
Patient Circuit W/ PEEP, 22mm, SPU
VYAIRE MEDICAL, INC.
29695-001
In Commercial Distribution

  • 50190752116007 ()
  • 10190752116009 ()
29695-001

  • Ventilator breathing circuit, single-use
Patient Circuit, W/ PEEP, 15mm, SPU
VYAIRE MEDICAL, INC.
11872x10
In Commercial Distribution

  • 50190752201536 ()
  • 10190752201538 ()
11872x10

  • Ventilator breathing circuit, single-use
SPU Gauge,Yellow/White, GE PL
AMERICAN DIAGNOSTIC CORP
809D
In Commercial Distribution

  • 00634782562731 ()
  • 00634782062927 ()
809D

  • Aneroid manual sphygmomanometer
Cooling Wrap, Standard Size, SPU, 1-ct
Dignitana AB
800-1102
In Commercial Distribution

  • 00850036106197 ()
800-1102

  • Scalp cooling system, hair loss
No Description
invendo medical GmbH
E210
Not in Commercial Distribution

  • 04260444390082 ()


  • Endoscopic control/video-imaging system
No Description
invendo medical GmbH
E210
Not in Commercial Distribution

  • 04260444390075 ()


  • Endoscopic control/video-imaging system
No Description
invendo medical GmbH
E200
Not in Commercial Distribution

  • 04260444390044 ()


  • Endoscopic control/video-imaging system
No Description
invendo medical GmbH
E200
Not in Commercial Distribution

  • 04260444390037 ()


  • Endoscopic control/video-imaging system
34" HoverMatt Plus HoverCover Kit
Hovertech International
HMHC-34
In Commercial Distribution

  • 00816299011685 ()
  • 00816299011692 ()

  • Width: 34 Inch
HMHC-34

  • Patient transfer system, powered
6450 V2 PET MASK SPU HG/FLEXMA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005543 ()
113824

  • Pulmonary function valve
6450 V2 XSM MASK SPU HG/FLEXMA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005536 ()
113823

  • Pulmonary function valve
ECG 5 LEAD GRABBER, AAMI, SPU, TELE
MEDLINE INDUSTRIES, INC.
03172031R
In Commercial Distribution

  • 20193489019053 ()
  • 10193489019056 ()
03172031R

  • Electrocardiographic lead set, reprocessed
ECG 5 LEAD GRABBER, IEC, SPU, TELE
MEDLINE INDUSTRIES, INC.
03172131R
In Commercial Distribution

  • 20193489018971 ()
  • 10193489018974 ()
03172131R

  • Electrocardiographic lead set, reprocessed
SPU Cuff, Infl System,Infant, Slip Conn
AMERICAN DIAGNOSTIC CORP
8600I
Not in Commercial Distribution

  • 00634782046194 ()

  • Infant, 8-13cm
8600I

  • Blood pressure cuff, reusable
SPU Cuff, Infl System,Child, Slip Conn
AMERICAN DIAGNOSTIC CORP
8600C
Not in Commercial Distribution

  • 00634782046187 ()

  • Child, 12-19cm
8600C

  • Blood pressure cuff, reusable
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