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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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LIFEPAK 35 Monitor/Defibrillator - 00883873765623

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765623 ()
70335-000041

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765616

LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN,STD,BT
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765616 ()
70335-000042

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765609

LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN
PHYSIO-CONTROL, INC.
99335
In Commercial Distribution

  • 00883873765609 ()
99335-000031

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765593

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN,STD,BT
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765593 ()
70335-000043

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765586

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN
PHYSIO-CONTROL, INC.
99335
In Commercial Distribution

  • 00883873765586 ()
99335-000032

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765463

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CP
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765463 ()
70335-000044

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765456

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CP
PHYSIO-CONTROL, INC.
99335
In Commercial Distribution

  • 00883873765456 ()
99335-000033

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765449

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CP
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765449 ()
70335-000045

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765432

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,WIFI/CELL/LN/CPRIN,STD,
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765432 ()
70335-000046

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765425

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,WIFI/CELL/LN/CPRIN,STD
PHYSIO-CONTROL, INC.
99335
In Commercial Distribution

  • 00883873765425 ()
99335-000034

  • Physiologic-monitoring defibrillation system

LIFEPAK 20e Defibrillator/Monitors - 00883873762400

USED ACLS LP20E CMM,PCNG,SPO2,EN
PHYSIO-CONTROL, INC.
96507
In Commercial Distribution

  • 00883873762400 ()
96507-000005U

  • Non-rechargeable professional semi-automated external defibrillator

LIFEPAK 20e Defibrillator/Monitors - 00883873762394

USED ACLS LP20E CMM,PCNG,ENG
PHYSIO-CONTROL, INC.
96507
In Commercial Distribution

  • 00883873762394 ()
96507-000004U

  • Non-rechargeable professional semi-automated external defibrillator

LIFEPAK 1000 defibrillator - 00883873762363

USED LP1000,EN,STD,ECG DISP,M
PHYSIO-CONTROL, INC.
99425
In Commercial Distribution

  • 00883873762363 ()
99425-000025U

  • Non-rechargeable professional semi-automated external defibrillator

LIFEPAK 20e Defibrillator/Monitors - 00883873762356

USED ACLS LP20E CMM,PCNG,MNC,SPO2,EN
PHYSIO-CONTROL, INC.
96507
In Commercial Distribution

  • 00883873762356 ()
96507-000006U

  • Non-rechargeable professional semi-automated external defibrillator

LIFEPAK 15 monitor/defibrillator - 00883873762264

USED 15AABBABBABBBAAAAAAAAABFLP15 MONITOR/DEFIB/
PHYSIO-CONTROL, INC.
96577
In Commercial Distribution

  • 00883873762264 ()
96577-000021U

  • Physiologic-monitoring defibrillation system

LIFEPAK 15 monitor/defibrillator - 00883873762257

USED 15AACBABBABBBAAAAAAAAABFLP15 MONITOR/DEFIB
PHYSIO-CONTROL, INC.
96577
In Commercial Distribution

  • 00883873762257 ()
96577-000022U

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761601

LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761601 ()
70335-000208

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761595

LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761595 ()
70335-000209

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761588

LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761588 ()
70335-000210

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761571

LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761571 ()
70335-000211

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761564

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761564 ()
70335-000212

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761557

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761557 ()
70335-000213

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761540

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761540 ()
70335-000214

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873761533

LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761533 ()
70335-000215

  • Physiologic-monitoring defibrillation system

PEDIATRIC PADDLE, EXTERNAL - 00883873761441

ASSY PEDIATRIC PADDLE,MULTI LANGUAGE, 3RD EDT
PHYSIO-CONTROL, INC.
11133
In Commercial Distribution

  • 00883873761441 ()
11133-000008

  • External defibrillation electrode, adult, reusable

STANDARD HARD PADDLES - 00883873761434

PADDLE ASSY - HARD PADDLE, ENGLISH,ROHS,LP15
PHYSIO-CONTROL, INC.
11130
In Commercial Distribution

  • 00883873761434 ()
11130-000143

  • External defibrillation electrode, adult, reusable

Aspirating Speculum(S) - 00883475954395

No Description
CHARMANT INC.
37-0015S
In Commercial Distribution

  • 00883475954395 ()


  • Eyelid speculum, reusable

Aspirating Speculum(L) - 00883475952131

No Description
CHARMANT INC.
37-0056
In Commercial Distribution

  • 00883475952131 ()


  • Eyelid speculum, reusable

LIFEPAK® CR Plus and LIFEPAK Express defibrillators - 00721902728372

PACKAGE-LPCR,SEMI,CIRCULATION PROMPT,200-300-360
PHYSIO-CONTROL, INC.
80403
Not in Commercial Distribution

  • 00721902728372 ()
80403-000110

  • Rechargeable public semi-automated external defibrillator

LIFEPAK® CR Plus and LIFEPAK Express defibrillators - 00721902728310

ASSY-LPCR+,SEMI,CIRCULATION PROMPT,200-300-360
PHYSIO-CONTROL, INC.
99403
Not in Commercial Distribution

  • 00721902728310 ()
99403-000110

  • Rechargeable public semi-automated external defibrillator

LIFEPAK® CR Plus and LIFEPAK Express defibrillators - 00721902678455

ASSY-LP CR PLUS.AUTO,CIRCULATION
PHYSIO-CONTROL, INC.
97403
Not in Commercial Distribution

  • 00721902678455 ()
97403-000005

  • Rechargeable public semi-automated external defibrillator

LIFEPAK® CR Plus and LIFEPAK Express defibrillators - 00721902677793

ASSY-LP CR PLUS, AUTO,BREATHING
PHYSIO-CONTROL, INC.
97403
Not in Commercial Distribution

  • 00721902677793 ()
97403-000003

  • Rechargeable public semi-automated external defibrillator

LIFEPAK® CR Plus and LIFEPAK Express defibrillators - 00721902677458

ASSY-LP CR PLUS,SEMI,CHECK FOR PULSE
PHYSIO-CONTROL, INC.
97403
Not in Commercial Distribution

  • 00721902677458 ()
97403-000001

  • Rechargeable public semi-automated external defibrillator

LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors - 00721902665301

LP20-CONFIGURED,W/PACING,SPO2,ENGLISH
PHYSIO-CONTROL, INC.
97402
Not in Commercial Distribution

  • 00721902665301 ()
97402-000003

  • Physiologic-monitoring defibrillation system

LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors - 00721902665233

LP20-CONFIGURED,WITH PACING,ENGLISH
PHYSIO-CONTROL, INC.
97402
Not in Commercial Distribution

  • 00721902665233 ()
97402-000002

  • Physiologic-monitoring defibrillation system

LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors - 00721902665103

LP20-CONFIGURED,W/O PACING,ENGLISH
PHYSIO-CONTROL, INC.
97402
Not in Commercial Distribution

  • 00721902665103 ()
97402-000001

  • Physiologic-monitoring defibrillation system

LIFEPAK® 500 Automated External Defibrillator - 00721902655203

LP500AACABAZZZZLP500EECGIAAAABBZZZZZ
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00721902655203 ()
99401-000840

  • Non-rechargeable public semi-automated external defibrillator

LIFEPAK® 500 Automated External Defibrillator - 00721902655197

LP500AACBBAZZZZLP500EECGIAAAAABZZZZZ
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00721902655197 ()
99401-000839

  • Non-rechargeable public semi-automated external defibrillator

Replacement Infant/Child AED Reduced Energy Electrodes - 00721902629013

ELECTASSY-AED INFANTCHILD REDUCED ENERGY-WW
PHYSIO-CONTROL, INC.
11101
In Commercial Distribution

  • 00721902629013 ()
  • 20721902629017 ()
11101-000016

  • External defibrillation electrode, paediatric, single-use

Replacement Infant/Child AED Reduced Energy Electrodes - 00721902629006

ELECTASSY-AED INFANTCHILD REDUCED ENERGY-DOM
PHYSIO-CONTROL, INC.
11101
In Commercial Distribution

  • 00721902629006 ()
  • 20721902629000 ()
11101-000015

  • External defibrillation electrode, paediatric, single-use

ST AIA-PACK ACTH - 14560189212517

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189212517 ()
  • 04560189212510 ()


  • Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)

ST AIA-PACK AFP - 14560189210230

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210230 ()
  • 04560189210233 ()


  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)

POLARIS™ 5.5 SPINAL SYSTEM - 00880304918825

No Description
BIOMET SPINE LLC
2000-5548
In Commercial Distribution

  • 00880304918825 ()

  • ANGLED BLADE HOOK, SMALL (6MM)
2000-5548

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304918818

No Description
BIOMET SPINE LLC
2000-5550
In Commercial Distribution

  • 00880304918818 ()

  • ANGLED BLADE HOOK, MEDIUM (7.5MM)
2000-5550

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304918801

No Description
BIOMET SPINE LLC
2000-5552
In Commercial Distribution

  • 00880304918801 ()

  • ANGLED BLADE HOOK, LARGE (9MM)
2000-5552

  • Bone-screw internal spinal fixation system, non-sterile

LIFEPAK® 12 defibrillator/monitor - 00721902301278

LP12AABBBBBAABBAAAAAAAAALP12 MONITOR-DEFIB
PHYSIO-CONTROL, INC.
97400
Not in Commercial Distribution

  • 00721902301278 ()
97400-000185

  • Physiologic-monitoring defibrillation system

LIFEPAK® 12 defibrillator/monitor - 00721902295249

LP12AABABBAABABBAABAAAAALP12 MONITOR-DEFIB
PHYSIO-CONTROL, INC.
99400
Not in Commercial Distribution

  • 00721902295249 ()
99400-001514

  • Physiologic-monitoring defibrillation system

LIFEPAK® 12 defibrillator/monitor - 00721902286872

LP12AABABBBABABBAABAAAAALP12 MONITOR-DEFIB
PHYSIO-CONTROL, INC.
99400
Not in Commercial Distribution

  • 00721902286872 ()
99400-001492

  • Physiologic-monitoring defibrillation system

LIFEPAK® 12 defibrillator/monitor - 00721902278921

LP12AABAABAABAABBABAAAAALP12 MONITOR-DEFIB
PHYSIO-CONTROL, INC.
99400
Not in Commercial Distribution

  • 00721902278921 ()
99400-001472

  • Physiologic-monitoring defibrillation system

LIFEPAK® 500 Automated External Defibrillator - 00721902275883

LP500AACAAZZZZZLP500EECGIAAAAEAZZZZZ
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00721902275883 ()
99401-000524

  • Non-rechargeable public semi-automated external defibrillator
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