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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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X SERIES - 00812394026241

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4, CONTAINS 610)
Zoll Medical Corporation
601-2221011-01-664
In Commercial Distribution

  • 00812394026241 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026180

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2231511-01-662
In Commercial Distribution

  • 00812394026180 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026173

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2231511-01-661
In Commercial Distribution

  • 00812394026173 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026166

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2231011-01-663
In Commercial Distribution

  • 00812394026166 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026159

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2231011-01-662
In Commercial Distribution

  • 00812394026159 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026142

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2231011-01-661
In Commercial Distribution

  • 00812394026142 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026135

X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2221511-01-663
In Commercial Distribution

  • 00812394026135 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026128

X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2221511-01-662
In Commercial Distribution

  • 00812394026128 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026111

X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2221511-01-661
In Commercial Distribution

  • 00812394026111 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026104

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2221011-01-663
In Commercial Distribution

  • 00812394026104 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026098

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2221011-01-662
In Commercial Distribution

  • 00812394026098 ()


  • Rechargeable professional automated external defibrillator

M330 - 00812394026043

ASPIRATOR, M330, US AIR FORCE, W/O BAG
Zoll Medical Corporation
8651-001202-01
In Commercial Distribution

  • 00812394026043 ()


  • Emergency airway clearance suction system, electric

731 ventilator - 00812394023462

MAIN ASSEMBLY, VENTILATOR, EMV+, COMMERCIAL, US, REFURBISHED
Zoll Medical Corporation
799-EMVP-01-01-66
In Commercial Distribution

  • 00812394023462 ()


  • Transport electric ventilator

Z Vent - 00812394023424

MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, REFURBISHED
Zoll Medical Corporation
799-EGB2-00-01-66
In Commercial Distribution

  • 00812394023424 ()


  • Transport electric ventilator

Z Vent - 00812394023417

DEVICE IDENTIFIER, MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, BASIC, REFURBISHED
Zoll Medical Corporation
799-AEB1-00-01-66
In Commercial Distribution

  • 00812394023417 ()


  • Transport electric ventilator

Z Vent - 00812394023394

DEVICE IDENTIFIER, VENTILATOR, EMV+, MRI, REFURB
Zoll Medical Corporation
800-EMVP-05-01-66
In Commercial Distribution

  • 00812394023394 ()


  • Transport electric ventilator

ZENIX - 00812394022823

CABLE, MFC, THOR, EC53
Zoll Medical Corporation
9500-000129
In Commercial Distribution

  • 00812394022823 ()


  • Electrocardiographic electrode connector

PATIENT CIRCUITS - 20847946023182

MASK, CPAP, #2, INFANT
Zoll Medical Corporation
812-0007-40
In Commercial Distribution

  • 20847946023182 ()


  • Transport electric ventilator

PATIENT CIRCUITS - 20847946023137

MASK, CPAP, #3, SM CHILD
Zoll Medical Corporation
812-0008-40
In Commercial Distribution

  • 20847946023137 ()


  • Transport electric ventilator

OSADA EXL-OSI2 - 04580406869877

No Description
OSADA ELECTRIC CO.,LTD.
EXL-OSI2
In Commercial Distribution

  • 04580406869877 ()
3299

  • Surgical power tool system control unit, line-powered
  • Line-powered dental drilling system
  • Dental power tool system, line-powered

OSADA XL-30W - 04580406860621

No Description
OSADA ELECTRIC CO.,LTD.
XL-30W
In Commercial Distribution

  • 04580406860621 ()
3123

  • Dental power tool system, line-powered
  • Line-powered dental drilling system
  • Surgical power tool system control unit, line-powered

OSADA XL-S30 - 04580406860614

No Description
OSADA ELECTRIC CO.,LTD.
XL-S30
In Commercial Distribution

  • 04580406860614 ()
3159

  • Line-powered dental drilling system
  • Surgical power tool system control unit, line-powered
  • Dental power tool system, line-powered

OSADA PEDO-30W - 04580406860485

No Description
OSADA ELECTRIC CO.,LTD.
PEDO-30W
In Commercial Distribution

  • 04580406860485 ()
3121

  • Dental power tool system, line-powered
  • Surgical power tool system control unit, line-powered
  • Line-powered dental drilling system

OSADA XL-S40 - 04582227436856

No Description
OSADA ELECTRIC CO.,LTD.
XL-S40
Not in Commercial Distribution

  • 04582227436856 ()
3285

  • Dental power tool system, line-powered
  • Line-powered dental drilling system
  • Surgical power tool system control unit, line-powered

Disposable Electrode Serie - 06924274950608

No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution

  • 06924274950608 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

Alias Lingual Bracket - 00889989080636

U5 ALIAS LINGUAL 18 0/0/0
ORMCO CORPORATION
369-0050
In Commercial Distribution

  • 20889989080630 ()
  • 00889989080636 ()

  • Slot size 018, Torque 0, Angulation 0


  • Orthodontic bracket, metal

Alias Lingual Bracket - 00889989080667

L6 ALIAS LINGUAL 18 0/0/0
ORMCO CORPORATION
369-0080
In Commercial Distribution

  • 20889989080661 ()
  • 00889989080667 ()

  • Slot size 018, Torque 0, Angulation 0


  • Orthodontic bracket, metal

AADCO - 00840348527346

24"x36" 0.8mm (18mm) .8MM CLEAR LEAD ACRYLIC ACTUAL CUT 24"X35 15/16"
AADCO MEDICAL, INC.
SC-714
In Commercial Distribution

  • 00840348527346 ()
SC-714

  • Radiation shielding panel, fixed

PORTA SHIELD - 00840186698222

PTSSHIELD1 (DRAPE ONLY FOR PORTA SHIELD PTS1 24"L X 24"), .5mm Regular Lead
BURLINGTON MEDICAL, LLC
PTSSHIELD1
In Commercial Distribution

  • 00840186698222 ()


  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST2424S9

DELUXE SHIELD - 24 x 24 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T2424S
In Commercial Distribution

  • G242LPST2424S90 ()
  • G242LPST2424S9 ()
LPS-T2424S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSS24249

STANDARD SHIELD - 24 x 24 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPS-S2424
In Commercial Distribution

  • G242LPSS242490 ()
  • G242LPSS24249 ()
LPS-S2424

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSGS24249

STANDARD SHIELD - 24 x 24 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2424
In Commercial Distribution

  • G242LPSGS242490 ()
  • G242LPSGS24249 ()
LPSG-S2424

  • Radiation shielding panel, portable/mobile

ICU Medical - 00887709019898

55" 24 Hour Smallbore Ext Set w/Bravo 24®, 2 Clamps, Rotating Luer
ICU MEDICAL, INC.
B9977
In Commercial Distribution

  • 10887709019895 ()
  • 00887709019898 ()


  • Basic intravenous administration set, noninvasive

Fantasy Assorted Lubricated Condoms - 20726893114016

Fantasy Assorted case of 12-packs (24 Lubricated, 24 3 Styles Assorted)( case of 48)
GLOBAL PROTECTION CORP.
L610002C
In Commercial Distribution

  • 80726893114018 ()
  • 20726893114016 ()


  • Basic male condom, Hevea-latex

Lexie Hearing - 00850022464577

Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 00850022464577 ()
  • 10850022464574 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal

Lexie B1, Powered by Bose - 00850022464492

Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
LB1001
In Commercial Distribution

Online

  • Air-conduction hearing aid, receiver-in-canal

Miris Human Milk Analyzer™ - 17350107530079

The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories. The Miris HMA is also intended for use by personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks, for the purpose of labeling milk donations and in the processing of milk donations.
Miris AB
Miris HMA US
In Commercial Distribution

  • 27350107530076 ()
  • 17350107530079 ()
08-02-107

  • Breast milk analyser IVD

Medfusion - 15019517130928

67-2586-0100-01 is an electronic file. There is no packaging.
ICU MEDICAL, INC.
67-2586-0100-01
In Commercial Distribution

  • 15019517130928 ()

  • Outer Diameter: 0 Millimeter
  • Length: 0 Millimeter
  • Width: 0 Millimeter
  • Circumference: 0 Millimeter
  • 0
  • Depth: 0 Millimeter


  • Infusion pump medication-dosage application software

Xhibit - 10841522127052

KIT, MULTI-BAND, WO/PS, PLEN, ACT ANT,ADC
SPACELABS HEALTHCARE (WASHINGTON), INC
Xhibit Central
In Commercial Distribution

  • 10841522127052 ()
040-1429-04

  • Electrocardiography monitoring system receiver

Spacelabs Healthcare - 10841522124754

KIT,DUAL ANT,ACTV,W/O PS,UHF,HI LVL,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
Not in Commercial Distribution

  • 10841522124754 ()
040-0388-02

  • Electrocardiography monitoring system receiver

Lifecard CF - 10841522123313

LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF; LCF_CBL; PXCABLES
Not in Commercial Distribution

  • 10841522123313 ()
19-7509

  • Electrical-only medical device connection cable, reusable

Sentinel - 10841522123252

SENTINEL 10.0.1 OFFLINE/NETWORK WORKSTAT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123252 ()
040-1705-00

  • Cardiology information system application software

Sentinel - 10841522123238

SENTINEL 10.0.1 ADD. NETWORK WORKSTAT LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123238 ()
040-1704-00

  • Cardiology information system application software

SENTINEL - 10841522123221

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123221 ()
040-1713-00

  • Cardiology information system application software

SENTINEL - 10841522123207

SENTINEL 10 TEST SYSTEM, RDT
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123207 ()
040-1725-00

  • Cardiology information system application software

Sentinel - 10841522123184

SENTINEL 10 TEST SYSTEM, STAND ALONE (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123184 ()
040-1722-00

  • Cardiology information system application software

SPACELABS HEALTHCARE - 10841522123146

PATIENT CABLE 2 CHANNEL, RED/YEL/GRN
SPACELABS HEALTHCARE (WASHINGTON), INC
PXCABLES
In Commercial Distribution

  • 10841522123146 ()
23-0051

  • Electrical-only medical device connection cable, reusable

SPACELABS HEALTHCARE - 10841522123061

VARIOS YOKE WITH 700-0331-00 LONG CABLE AHA,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF; LCF_CBL; PXCABLES
Not in Commercial Distribution

  • 10841522123061 ()
700-0365-00

  • Electrical-only medical device connection cable, reusable

SPACELABS HEALTHCARE - 10841522122811

PEDIATRIC FLOW SENSOR SINGLE ITEM KIT
SPACELABS HEALTHCARE (WASHINGTON), INC
700900V
In Commercial Distribution

  • 10841522122811 ()
376-0561-01

  • Breathing circuit gas-flow sensor, reusable

Trulink - 10841522122798

LDWR SET,SNAP,ECG,127CM/50IN,AAMI,5LW/SET,BX/25
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522122798 ()
700-0007-32

  • Electrocardiographic lead set, reusable
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