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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PROSCOPE SPU Scope,32", Yellow, 10/pkg
AMERICAN DIAGNOSTIC CORP
665Y-10
In Commercial Distribution

  • 00634782506162 ()
  • 00634782806163 ()
  • 00634782006174 ()
665Y-10

  • Mechanical external stethoscope
Thermal Cap, Universal Size, SPU, Qty 10
Dignitana AB
800-1004
In Commercial Distribution

  • 00850036106333 ()
  • 00850036106241 ()
800-1004

  • Scalp cooling system, hair loss
Cooling Wrap, Small Size, SPU, Qty 10
Dignitana AB
800-1003
In Commercial Distribution

  • 00850036106326 ()
  • 00850036106227 ()
800-1003

  • Scalp cooling system, hair loss
Cooling Wrap, Standard Size, SPU, Qty 10
Dignitana AB
800-1002
In Commercial Distribution

  • 00850036106319 ()
  • 00850036106203 ()
800-1002

  • Scalp cooling system, hair loss
SPU SmartVest Wrap® – S–XXL – 5-Pack
ELECTROMED, INC.
SW-MULTI-5
In Commercial Distribution

  • B102060154S0105 ()
SW-MULTI-5

  • Chest-oscillation airway secretion-clearing system vest
MASK,VENTURI,PED,CURAPLEX,SPU 50/CA
BOUND TREE MEDICAL, LLC
301-192
In Commercial Distribution

  • 00812277036350 ()
  • 00812277036343 ()
301-192

  • Venturi oxygen face mask
Regard HoverMatt® SPU Air Transfer Mattress
Cardinal Health 200, LLC
RGMT50FL-REG-B
In Commercial Distribution

  • 10885380203237 ()
RGMT50FL-REG-B

  • Inflatable patient transfer sliding mattress, reprocessed
Regard HoverMatt® SPU Air Transfer Mattress
Cardinal Health 200, LLC
RGMT39HLF-REG-B
In Commercial Distribution

  • 10885380203220 ()
RGMT39HLF-REG-B

  • Inflatable patient transfer sliding mattress, reprocessed
Regard HoverMatt® SPU Air Transfer Mattress
Cardinal Health 200, LLC
RGMT39FL-REG-B
In Commercial Distribution

  • 10885380203213 ()
RGMT39FL-REG-B

  • Inflatable patient transfer sliding mattress, reprocessed
Regard HoverMatt® SPU Air Transfer Mattress
Cardinal Health 200, LLC
RGMT34HLF-REG-B
In Commercial Distribution

  • 10885380203206 ()
RGMT34HLF-REG-B

  • Inflatable patient transfer sliding mattress, reprocessed
Regard HoverMatt® SPU Air Transfer Mattress
Cardinal Health 200, LLC
RGMT34FL-REG-B
In Commercial Distribution

  • 10885380203190 ()
RGMT34FL-REG-B

  • Inflatable patient transfer sliding mattress, reprocessed
MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA
BOUND TREE MEDICAL, LLC
301-184
In Commercial Distribution

  • 00810071630880 ()
  • 00810071631283 ()
301-184

  • Tracheostomy mask, oxygen
6450 V2 SM MASK SPU HG/FLEX MA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005529 ()
113822

  • Pulmonary function valve
6450 V2 MD MASK SPU HG/FLEX MA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005512 ()
113821

  • Pulmonary function valve
6450 V2 LG MASK SPU HG/FLEX MA
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00874750005505 ()
113820

  • Pulmonary function valve
ADCUFF SPU Inflation System,Thigh, Brown, 5/pkg
AMERICAN DIAGNOSTIC CORP
8650-13T
In Commercial Distribution

  • 00634782586485 ()
  • 00634782886486 ()
  • 00634782085087 ()

  • Thigh, 45-56.5cm
8650-13T

  • Blood pressure cuff, reusable
ADCUFF SPU Inflation System,Adult, Navy, 5/pkg
AMERICAN DIAGNOSTIC CORP
8650-11A
In Commercial Distribution

  • 00634782586447 ()
  • 00634782886448 ()
  • 00634782085049 ()

  • Adult, 27.5-36.5cm
8650-11A

  • Blood pressure cuff, reusable
ADCUFF SPU Inflation System,Child, Green, 5/pkg
AMERICAN DIAGNOSTIC CORP
8650-9C
In Commercial Distribution

  • 00634782586423 ()
  • 00634782886424 ()
  • 00634782085025 ()

  • Child, 13.8-21.5cm
8650-9C

  • Blood pressure cuff, reusable
ADCUFF SPU Inflation System,Infant, Orange, 5/pkg
AMERICAN DIAGNOSTIC CORP
8650-7I
In Commercial Distribution

  • 00634782586416 ()
  • 00634782886417 ()
  • 00634782085018 ()

  • Infant, 9-14.8cm
8650-7I

  • Blood pressure cuff, reusable
Patient Circuit W/O PEEP, 22mm, SPU, 15'
VYAIRE MEDICAL, INC.
19189-001
In Commercial Distribution

  • 50190752130171 ()
  • 10190752130173 ()
19189-001

  • Carpal lunate prosthesis
Patient Circuit W/O PEEP, 22mm, SPU, 15'
VYAIRE MEDICAL, INC.
29665-001
Not in Commercial Distribution

  • 50190752115994 ()
  • 10190752115996 ()
29665-001

  • Ventilator breathing circuit, single-use
Patient Circuit W/O PEEP, 22mm, SPU, 15'
VYAIRE MEDICAL, INC.
29665-001
In Commercial Distribution

  • 50190752201529 ()
  • 10190752201521 ()
29665-001

  • Ventilator breathing circuit, single-use
PROSCOPE SPU Scope,32", Royal Blue, 100/cs
AMERICAN DIAGNOSTIC CORP
665RB-100
In Commercial Distribution

  • 00634782546328 ()
  • 00634782046514 ()
665RB-100

  • Mechanical external stethoscope
PROSCOPE SPU Scope,32", Royal Blue, 10/pkg
AMERICAN DIAGNOSTIC CORP
665RB-10
In Commercial Distribution

  • 00634782546311 ()
  • 00634782846312 ()
  • 00634782046507 ()
665RB-10

  • Mechanical external stethoscope
SPU Cuff, Infl System,Lrg Adult, Slip Conn
AMERICAN DIAGNOSTIC CORP
8600X
Not in Commercial Distribution

  • 00634782046224 ()

  • Large Adult, 31-40cm
8600X

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

  • 00634782046217 ()

  • Small Adult, 17-25cm
8600SA

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

  • 00634782046200 ()

  • Long Adult, 23-33cm
8600LA

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Size 5, Slip Conn
AMERICAN DIAGNOSTIC CORP
8505N
Not in Commercial Distribution

  • 00634782046163 ()

  • Neonatal Size 5, 8-15cm
8505N

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Size 4, Slip Conn
AMERICAN DIAGNOSTIC CORP
8504N
Not in Commercial Distribution

  • 00634782046156 ()

  • Neonatal Size 4, 7-13cm
8504N

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Size 3, Slip Conn
AMERICAN DIAGNOSTIC CORP
8503N
In Commercial Distribution

  • 00634782046149 ()

  • Neonatal Size 3, 6-11cm
8503N

  • Blood pressure cuff, reusable
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