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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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
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
SPU Cuff, 1 Tube,Size 2, Slip Conn
AMERICAN DIAGNOSTIC CORP
8502N
In Commercial Distribution

  • 00634782046132 ()

  • Neonatal Size 2, 4-8cm
8502N

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Size 1, Slip Conn
AMERICAN DIAGNOSTIC CORP
8501N
In Commercial Distribution

  • 00634782046125 ()

  • Neonatal Size 1, 3-6cm
8501N

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Lrg Adult, Slip Conn
AMERICAN DIAGNOSTIC CORP
8500X3
Not in Commercial Distribution

  • 00634782046118 ()

  • Large Adult, 31-40cm
8500X3

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Lrg Adult, Bayonet Conn
AMERICAN DIAGNOSTIC CORP
8500X2
Not in Commercial Distribution

  • 00634782046101 ()

  • Large Adult, 31-40cm
8500X2

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Lrg Adult, Female Conn
AMERICAN DIAGNOSTIC CORP
8500X1
Not in Commercial Distribution

  • 00634782046095 ()

  • Large Adult, 31-40cm
8500X1

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Small Adult, Slip Conn
AMERICAN DIAGNOSTIC CORP
8500SA3
Not in Commercial Distribution

  • 00634782046088 ()

  • Small Adult, 17-25cm
8500SA3

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Small Adult, Bayonet Conn
AMERICAN DIAGNOSTIC CORP
8500SA2
Not in Commercial Distribution

  • 00634782046071 ()

  • Small Adult, 17-25cm
8500SA2

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Small Adult, Female Conn
AMERICAN DIAGNOSTIC CORP
8500SA1
Not in Commercial Distribution

  • 00634782046064 ()

  • Small Adult, 17-25cm
8500SA1

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Long Adult, Slip Conn
AMERICAN DIAGNOSTIC CORP
8500LA3
Not in Commercial Distribution

  • 00634782046057 ()

  • Long Adult, 23-33cm
8500LA3

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Long Adult, Bayonet Conn
AMERICAN DIAGNOSTIC CORP
8500LA2
Not in Commercial Distribution

  • 00634782046040 ()

  • Long Adult, 23-33cm
8500LA2

  • Blood pressure cuff, reusable
SPU Cuff, 1 Tube,Long Adult, Female Conn
AMERICAN DIAGNOSTIC CORP
8500LA1
Not in Commercial Distribution

  • 00634782046033 ()

  • Long Adult, 23-33cm
8500LA1

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Size 5, Slip Conn
AMERICAN DIAGNOSTIC CORP
8405N
In Commercial Distribution

  • 00634782045937 ()

  • Neonatal Size 5, 8-15cm
8405N

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Size 4, Slip Conn
AMERICAN DIAGNOSTIC CORP
8404N
In Commercial Distribution

  • 00634782045920 ()

  • Neonatal Size 4, 7-13cm
8404N

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Size 3, Slip Conn
AMERICAN DIAGNOSTIC CORP
8403N
In Commercial Distribution

  • 00634782045913 ()

  • Neonatal Size 3, 6-11cm
8403N

  • Blood pressure cuff, reusable
SPU Cuff, 2 Tube,Size 2, Slip Conn
AMERICAN DIAGNOSTIC CORP
8402N
In Commercial Distribution

  • 00634782045906 ()

  • Neonatal Size 2, 4-8cm
8402N

  • Blood pressure cuff, reusable
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