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 Cuff, 2 Tube,Child, Screw Conn
AMERICAN DIAGNOSTIC CORP
8400C1-10
Not in Commercial Distribution

  • 00634782044640 ()
  • 00634782844479 ()

  • Child, 12-19cm
8400C1-10

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Child, Slip Conn
AMERICAN DIAGNOSTIC CORP
8400C2-10
Not in Commercial Distribution

  • 00634782044633 ()
  • 00634782844462 ()

  • Child, 12-19cm
8400C2-10

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Infant, Female Conn
AMERICAN DIAGNOSTIC CORP
8400I3-10
Not in Commercial Distribution

  • 00634782044626 ()
  • 00634782844455 ()

  • Infant, 8-13cm
8400I3-10

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Infant, Screw Conn
AMERICAN DIAGNOSTIC CORP
8400I1-10
Not in Commercial Distribution

  • 00634782044619 ()
  • 00634782844448 ()

  • Infant, 8-13cm
8400I1-10

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Infant, Slip Conn
AMERICAN DIAGNOSTIC CORP
8400I2-10
Not in Commercial Distribution

  • 00634782044602 ()
  • 00634782844431 ()

  • Infant, 8-13cm
8400I2-10

  • Blood pressure cuff, reusable
PROSCOPE SPU Scope,32", Yellow, 100/cs
AMERICAN DIAGNOSTIC CORP
665Y-100
In Commercial Distribution

  • 00634782506179 ()
  • 00634782006181 ()
665Y-100

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

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

  • Mechanical external stethoscope
SPU Digital Thermometer Kit,Rectal, KM PL
AMERICAN DIAGNOSTIC CORP
413RKKM
In Commercial Distribution

  • 00634782595302 ()
  • 00634782895303 ()
  • 00634782093884 ()
413RKKM

  • Intermittent electronic patient thermometer
SPU Digital Thermometer Kit,Oral, KM PL
AMERICAN DIAGNOSTIC CORP
413KKM
In Commercial Distribution

  • 00634782595296 ()
  • 00634782895297 ()
  • 00634782093877 ()
413KKM

  • Intermittent electronic patient thermometer
MASK,VENTURI,PED,CURAPLEX,SPU 50/CA
BOUND TREE MEDICAL, LLC
301-192
In Commercial Distribution

  • 00812277036350 ()
  • 00812277036343 ()
301-192

  • Venturi oxygen face mask
MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA
BOUND TREE MEDICAL, LLC
301-184
In Commercial Distribution

  • 00810071630880 ()
  • 00810071631283 ()
301-184

  • Tracheostomy mask, oxygen
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
ABP CUFF,SPACELABS,1T,XLADULT,SPU,20/BX
Statcorp Medical
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522123870 ()

  • 42 cm-50 cm ID
015-4250-00

  • Blood pressure cuff, single-use
ABP CUFF,SPACELABS,1T,ADULT,SPU,20/BX
Statcorp Medical
SoftCheck BP Cuffs
In Commercial Distribution

  • 10841522123856 ()
015-2635-00

  • Blood pressure cuff, single-use
SENSOR,SPO2,CLOTH,NEO,SPU,24/BX,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522102387 ()
  • 00841522102380 ()
015-0667-00

  • Pulse oximeter probe, reusable
SENSOR,SPO2,CLOTH,INFANT,SPU,24/BX,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522102370 ()
  • 00841522102373 ()
015-0666-00

  • Pulse oximeter probe, reusable
SENSOR,SPO2,VINYL,PEDIATRIC,SPU,24/BX,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522102363 ()
  • 00841522102366 ()
015-0665-00

  • Pulse oximeter probe, reusable
SENSOR,SPO2,FOAM,PEDIATRIC,SPU,24/BX,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522102356 ()
  • 00841522102359 ()
015-0664-00

  • Pulse oximeter probe, reusable
SENSOR,SPO2,VINYL,ADULT,SPU,24/BX,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522102349 ()
  • 00841522102342 ()
015-0663-00

  • Pulse oximeter probe, reusable
SENSOR,SPO2,FOAM,ADULT,SPU,24/BX,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522102332 ()
  • 00841522102335 ()
015-0662-00

  • Pulse oximeter probe, reusable
Contour Deluxe Mask and Headgear, SPU, Small, Korea
Respironics, Inc.
Contour Deluxe Mask and Headgear, SPU, Small, Korea
Not in Commercial Distribution

  • 30606959024879 ()
  • 00606959024878 ()
1124581

  • CPAP/BPAP nasal mask, 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
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.
19189-001
In Commercial Distribution

  • 50190752130171 ()
  • 10190752130173 ()
19189-001

  • Carpal lunate prosthesis
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
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
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