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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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E SERIES - 00847946024550

MAIN, AED-2, 12 LEAD, SPO2/ETCO2/NIBP, GPS/BT, LI-ION, AC, NO RAILS, DMST, REFURB
Zoll Medical Corporation
80011730020064013
In Commercial Distribution

  • 00847946024550 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator

E SERIES - 00847946024543

MAIN, AED-2, 3/5 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS, AC, NO RAILS, DMST, REFURB
Zoll Medical Corporation
80010810010064013
In Commercial Distribution

  • 00847946024543 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator

E SERIES - 00847946024536

MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, RAILS, VOICE, DMST, REFURB
Zoll Medical Corporation
80001730020174012
In Commercial Distribution

  • 00847946024536 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator

E SERIES - 00847946024529

MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, RAILS W/ PAD. WELL, DMST, REFURB
Zoll Medical Corporation
80001710030124011
In Commercial Distribution

  • 00847946024529 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator

M SERIES BIPHASIC - 00847946024505

MAIN,ACLS/MNL-1,12LEAD,SPO2,ETCO2,NIBP,BIPHASIC,EL,DC,PC,RC,SM,CM,BLUETOOTH,ENG, REFURB
Zoll Medical Corporation
60021721110123010
In Commercial Distribution

  • 00847946024505 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system

M SERIES - 00847946024499

MAIN, AED 3/5LEAD/SP02/AC/BIPH/EL/RC/SM/CM/ENG, REFURB
Zoll Medical Corporation
60010211100073010
In Commercial Distribution

  • 00847946024499 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

R SERIES - 00847946024482

MAIN,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,NELLCOR COMP,W/PACE,ADVISORY,CF/USB, ENG, REFURB
Zoll Medical Corporation
10000002001110012
In Commercial Distribution

  • 00847946024482 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system

AED PLUS - 00847946024475

MAIN ASSY, PS SERIES, ECG ON, LCD, NO VOICE RCDG, ENGLISH, REFURB
Zoll Medical Corporation
70000800100011010
In Commercial Distribution

  • 00847946024475 ()

  • 5.25" x 9.5" x 11.5"


  • Rechargeable professional automated external defibrillator

AED PLUS - 00847946024468

MAIN ASSY, AED PLUS, PA SERIES, NO GRAPHICS, W/BASIC CVR, NO LCD, NO VOICE RCDG, NO CPR, ENG, REFURB
Zoll Medical Corporation
70000100201000010
In Commercial Distribution

  • 00847946024468 ()

  • 5.25" x 9.5" x 11.5"


  • Rechargeable professional automated external defibrillator

X SERIES - 00847946024451

Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK AND ETCO2, VOICE, DMST, REFURB
Zoll Medical Corporation
620-2431011-01-66
In Commercial Distribution

  • 00847946024451 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system

X SERIES - 00847946024383

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST REFURB
Zoll Medical Corporation
620-2231511-01-66
In Commercial Distribution

  • 00847946024383 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system

X SERIES - 00847946024314

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, IBP/TEMP, PACING, NIBP, SPO2, CPR EXPANSION PACK, DMST,REFURB
Zoll Medical Corporation
620-0210511-01-66
In Commercial Distribution

  • 00847946024314 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system

AED PLUS - 00847946024291

Defibrillator ,MAIN ASSY, PS SERIES, FULLY AUTOMATIC, LCD, NO VOICE RCDG, AHA SPANISH
Zoll Medical Corporation
20000700700011230
In Commercial Distribution

  • 00847946024291 ()

  • 5.25" x 9.5" x 11.5"


  • Rechargeable professional automated external defibrillator

X SERIES - 00847946024260

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, PACING, NO NIBP, SPO2, ETCO2, IBP, CPR EXPANSION PACK , DMST
Zoll Medical Corporation
620-0221301-01
In Commercial Distribution

  • 00847946024260 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system

X SERIES - 00847946024253

MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST
Zoll Medical Corporation
620-0121511-01-66
In Commercial Distribution

  • 00847946024253 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system

R SERIES - 00847946024246

MAIN,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,NELLCOR COMP,W/PACE,ADVISORY,CF/USB, ENG, REFURB
Zoll Medical Corporation
10020002001110012
In Commercial Distribution

  • 00847946024246 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system

AED PLUS - 00847946024239

MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, 50HZ, SPANISH
Zoll Medical Corporation
20000000100011100
In Commercial Distribution

  • 00847946024239 ()

  • 5.25" x 9.5" x 11.5"


  • Rechargeable professional automated external defibrillator

AED PLUS - 00847946024222

MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, 60HZ, FRENCH
Zoll Medical Corporation
20000000100011260
In Commercial Distribution

  • 00847946024222 ()

  • 5.25" x 9.5" x 11.5"


  • Rechargeable professional automated external defibrillator

LoFlo Sidestream Consumables - 00847946024086

KIT, ADAPTER, AIRWAY, W/DEHUMID TUBING, PEDIATRIC/INFANT, BOX OF 10, (REF: 3573INF-00)
Zoll Medical Corporation
9355-0315
In Commercial Distribution

  • 00847946024086 ()


  • Gas-sampling/monitoring respiratory tubing, single-use

REUSABLE AIRWAY ADAPTER - 00847946024055

NEONATAL REUSABLE AIRWAY ADAPTER
Zoll Medical Corporation
9355-0303
In Commercial Distribution

  • 00847946024055 ()


  • Physiologic-monitoring defibrillation system

LoFlo Sidestream Consumables - 00847946024017

KIT, ADAPTER, AIRWAY, W/DEHUMID TUBING, ADULT/PEDIATRIC, BOX OF 10, (REF: 3573ADU-00)
Zoll Medical Corporation
9355-0277
In Commercial Distribution

  • 00847946024017 ()


  • Gas-sampling/monitoring respiratory tubing, single-use

LoFlo Sidestream Consumables - 00847946023997

CANNULA, ORAL/NASAL, PEDIATRIC, CO2, W/O2, BOX OF 10, (REF: 3571PED-00)
Zoll Medical Corporation
9355-0274
In Commercial Distribution

  • 00847946023997 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling

LoFlo Sidestream Consumables - 00847946023973

CANNULA, NASAL, PEDIATRIC, CO2/WO2, BOX OF 10, (REF: 3569PED-00)
Zoll Medical Corporation
9355-0271
In Commercial Distribution

  • 00847946023973 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling

LoFlo Sidestream Consumables - 00847946023959

CANNULA, ORAL/NASAL, PEDIATRIC, CO2 SAMPLING, BOX OF 10, (REF: 3570PED-00)
Zoll Medical Corporation
9355-0269
In Commercial Distribution

  • 00847946023959 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling

N/A - 04961333242153

5197-801 ZOOM COUPLER, 17.5MM
PENTAX OF AMERICA, INC.
9118B
In Commercial Distribution

  • 04961333242153 ()

  • Length: 37.0 Millimeter


  • Endoscope camera adaptor

Azostix® Reagent Strips - 00630414551142

AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.
Siemens Healthcare Diagnostics Inc.
10324060
In Commercial Distribution

  • 00630414551142 ()
  • 00630414009544 ()
A2830C16

  • Urea IVD, kit, enzyme spectrophotometry

Multistix® Reagent Strips - 00630414551111

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen.
Siemens Healthcare Diagnostics Inc.
10339953
In Commercial Distribution

  • 00630414551111 ()
  • 00630414009735 ()
A2179B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Albustix® Reagent Strips - 00630414550602

ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.
Siemens Healthcare Diagnostics Inc.
10333485
In Commercial Distribution

  • 00630414550602 ()
  • 00630414009650 ()
A2191B16

  • Urine protein IVD, kit, rapid colorimetric, clinical

Multistix PRO® 10LS Reagent Strips - 00630414549262

Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
Siemens Healthcare Diagnostics Inc.
10332782
In Commercial Distribution

  • 00630414549262 ()
  • 00630414009643 ()
A1566C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Multistix PRO® 10LS Reagent Strips - 00630414549255

Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
Siemens Healthcare Diagnostics Inc.
10331147
In Commercial Distribution

  • 00630414549255 ()
  • 00630414009636 ()
A1554C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Uristix® Reagent Strips - 00630414549132

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein and glucose.
Siemens Healthcare Diagnostics Inc.
10339520
In Commercial Distribution

  • 00630414549132 ()
  • 00630414009728 ()
A2184B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Combistix® Reagent Strips - 00630414549125

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, glucose and pH.
Siemens Healthcare Diagnostics Inc.
10337932
In Commercial Distribution

  • 00630414549125 ()
  • 00630414009704 ()
A2183B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Hema-Combistix® Reagent Strips - 00630414549118

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose and pH.
Siemens Healthcare Diagnostics Inc.
10338451
In Commercial Distribution

  • 00630414549118 ()
  • 00630414009711 ()
A2182B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Uristix® 4 Reagent Strips - 00630414549057

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, leukocytes, nitrite, glucose.
Siemens Healthcare Diagnostics Inc.
10312569
In Commercial Distribution

  • 00630414549057 ()
  • 00630414009377 ()
A2166B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Multistix® 7 Reagent Strips - 00630414549040

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid) and pH.
Siemens Healthcare Diagnostics Inc.
10326145
In Commercial Distribution

  • 00630414549040 ()
  • 00630414009582 ()
A2165C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Multistix® 8 SG Reagent Strips - 00630414549033

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH and specific gravity.
Siemens Healthcare Diagnostics Inc.
10337913
In Commercial Distribution

  • 00630414549033 ()
  • 00630414009698 ()
A2164C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Multistix® 9 SG Reagent Strips - 00630414549026

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and bilirubin
Siemens Healthcare Diagnostics Inc.
10337216
In Commercial Distribution

  • 00630414549026 ()
  • 00630414009681 ()
A2163B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Multistix® 9 Reagent Strips - 00630414549019

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen
Siemens Healthcare Diagnostics Inc.
10329874
In Commercial Distribution

  • 00630414549019 ()
  • 00630414009629 ()
A2162B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Multistix® 10 SG Reagent Strips - 00630414548968

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity, bilirubin and urobilinogen.
Siemens Healthcare Diagnostics Inc.
10336425
In Commercial Distribution

  • 00630414548968 ()
  • 00630414009667 ()
A2161B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

X SERIES - 00847946099497

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, PACING, SPO2, CPR EXPANSION, DMST
Zoll Medical Corporation
610-0210001-01
In Commercial Distribution

  • 00847946099497 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator

ZOLL BATTERY LI-ION - 00847946099480

ASSY, BATTERY, SUREPOWER II, US MILITARY
Zoll Medical Corporation
1017-001100-30
In Commercial Distribution

  • 00847946099480 ()


  • Rechargeable professional automated external defibrillator

PROPAQ MD - 00847946099459

Defibrillator ,MAIN ASSY, PROPAQ MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, IBP, TEMP CPR EXPANSION PACK AND ETCO2, W/CP2, DMST, REFURB
Zoll Medical Corporation
310-2421312-01-66
In Commercial Distribution

  • 00847946099459 ()

  • 8.9" x 10.4" x 7.9"


  • Rechargeable professional automated external defibrillator

X SERIES - 00847946099442

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, IBP/TEMP, PACING, NIBP, SPO2, CPR EXPANSION PACK, DMST
Zoll Medical Corporation
610-0210511-01
In Commercial Distribution

  • 00847946099442 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator

AED PLUS - 00847946099435

Defibrillator ,MAIN ASSY, PS SERIES, LCD, VOICE, RCDG, JAPANESE
Zoll Medical Corporation
20000001100011360
Not in Commercial Distribution

  • 00847946099435 ()

  • 5.25" x 9.5" x 11.5"


  • Rechargeable professional automated external defibrillator

X SERIES - 00847946099404

Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, TEMP, ETCO2, DMST
Zoll Medical Corporation
610-0121510-01
In Commercial Distribution

  • 00847946099404 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator

X SERIES - 00847946099398

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST
Zoll Medical Corporation
620-2241511-01
In Commercial Distribution

  • 00847946099398 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator

AED PLUS - 00847946099381

Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, SPANISH, US
Zoll Medical Corporation
20000000100011230
In Commercial Distribution

  • 00847946099381 ()

  • 5.25" x 9.5" x 11.5"


  • Rechargeable professional automated external defibrillator

R SERIES - 00847946099367

Defibrillator, MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, SPO2, ETCO2,CF/STD, DMST
Zoll Medical Corporation
30001003101030012
In Commercial Distribution

  • 00847946099367 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

E SERIES - 00847946099336

Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RAILS, DMST
Zoll Medical Corporation
50011730030164013
In Commercial Distribution

  • 00847946099336 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator

AED 35MM Optical Coupler - 00848657070935

Optical Coupler: The device is designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
CPL 35
In Commercial Distribution

  • 00848657070935 ()
CPL 35

  • Endoscope camera adaptor
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