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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No Description
NAKANISHI INC.
iPA
In Commercial Distribution

  • 04560264533776 ()
  • 04589551383368 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
SBG/IPA BOLT
Smith & Nephew, Inc.
75001747
In Commercial Distribution

  • 07612883015908 ()
75001747

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Site-ScrubTM IPA Device
Bard Access Systems, Inc.
3882100
In Commercial Distribution

  • 00801741086946 ()
  • 10801741086943 ()


  • Intravenous line connector disinfection scrubber
Site-ScrubTM IPA Device
Bard Access Systems, Inc.
3882025
In Commercial Distribution

  • 00801741086939 ()
  • 10801741086936 ()


  • Intravenous line connector disinfection scrubber
HeartStart FRx Defibrillator
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861304
Not in Commercial Distribution

  • 00884838006560 ()
861304

  • Non-rechargeable public automated external defibrillator
HeartStart FRx Defibrillator
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Heartstart FRx
In Commercial Distribution

  • 00884838080768 ()
861304

  • Non-rechargeable public semi-automated external defibrillator
Guidelines Update, FRx
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861339
Not in Commercial Distribution

  • 00884838050716 ()
861339

  • Non-rechargeable public automated external defibrillator
Prep Applicator,PVP-I/IPA
Cardinal Health, Inc.
605039
In Commercial Distribution

  • 30884527006483 ()
  • 20884527006486 ()
  • 10884527006489 ()

  • Total Volume: 39 Milliliter
605039

  • Surgical personnel scrub preparation kit
FRX 2.0 Articualed Arm
ILOODA.CO.,LTD
FRX 2.0 Articualed Arm
In Commercial Distribution

  • 08800023200027 ()


  • Electrosurgical system
  • Dermatological carbon dioxide laser system
FRX 2.0 Main Unit
ILOODA.CO.,LTD
FRX 2.0 Main Unit
In Commercial Distribution

  • 08800023200010 ()


  • Dermatological carbon dioxide laser system
  • Electrosurgical system
FRx Aviation Battery Pack
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FRx Aviation Battery
In Commercial Distribution

  • 00884838023802 ()
989803139301

  • Primary battery
Guidelines Update, New FRx
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861338
Not in Commercial Distribution

  • 00884838050709 ()
861338

  • Non-rechargeable public automated external defibrillator
FRx Aviation Battery Pack
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FRx Aviation Battery
In Commercial Distribution

  • 00884838123939 ()
989803139301

  • Primary battery
FRX 2.0 Needle H/P
ILOODA.CO.,LTD
FRX 2.0 Needle H/P
In Commercial Distribution

  • 08800023200041 ()


  • Electrosurgical system
FRX 2.0 Scanner H/P
ILOODA.CO.,LTD
FRX 2.0 Scanner H/P
In Commercial Distribution

  • 08800023200034 ()


  • Dermatological carbon dioxide laser system
SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM
Smith & Nephew, Inc.
75007309
In Commercial Distribution

  • 07611996076394 ()
75007309

  • Orthopaedic implant-instrument extension adaptor, reusable
SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM
Smith & Nephew, Inc.
75007308
In Commercial Distribution

  • 07611996074895 ()
75007308

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 25MM
Smith & Nephew, Inc.
75007307
In Commercial Distribution

  • 07611996074888 ()
75007307

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SL-PLUS/SBG/IPA MIA OFFSET BOX CHISEL
Smith & Nephew, Inc.
75007254
In Commercial Distribution

  • 07611996065190 ()
75007254

  • Orthopaedic chisel
Ethanol (90%) MeOH (4.5%) IPA (5.5%) BTL/250ml
REMEL, INC.
R40132
In Commercial Distribution

  • 00848838065835 ()
R40132

  • Acid-alcohol solution IVD
SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13
Smith & Nephew, Inc.
75007311
In Commercial Distribution

  • 07611996081503 ()
75007311

  • Orthopaedic implant-instrument extension adaptor, reusable
SL/SBG/IPA MIA DOUBLE OFFSET ADAP.L17/13
Smith & Nephew, Inc.
75007310
In Commercial Distribution

  • 07611996081497 ()
75007310

  • Orthopaedic implant-instrument extension adaptor, reusable
99% IPA bottle for use with the Firefly system
PURACATH MEDICAL, INC
40595
Not in Commercial Distribution

  • 00865349000353 ()


  • Luer-formatted disinfection cap
Lithium replacement battery for Philips(TM) Heartstart(TM) FRx Onsite & Home(TM) AED.
Amco International Manufacturing & Design, Inc.
AM5070
In Commercial Distribution

  • 00853258006054 ()
AM5070

  • Primary battery
AMShield® Disinfecting Cap Contains 70% IPA for Needle-Free Valves 200 PCS Individually Packed
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411011874 ()
  • 30704411011877 ()
  • 00704411011876 ()
DCF2000

  • Luer-formatted disinfection cap
Lithium Manganese Dioxide battery for replacement in Philips(TM) Heartstart(TM) FRx Onsite & Home(TM).
AED BATTERY EXCHANGE, LLC
5070-ABE
In Commercial Distribution

  • 00864312000208 ()


  • Primary battery
AMShield® Disinfecting Cap Contains 70% IPA for Needle-Free Valves 10 Pieces Mounted on a Strip
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411011867 ()
  • 30704411011860 ()
  • 00704411011869 ()
DCF2500S

  • Luer-formatted disinfection cap
SYRINGE, SWABFLUSH, 3/10ML, W/SWABCAP
MEDLINE INDUSTRIES, INC.
EMZE010335
In Commercial Distribution

  • 10888277675872 ()
EMZE010335

  • Vascular access device flush/disinfection tool
DBD-SWABKIT,2.5ML,SALINE,3ML,SYRINGE,STE
MEDLINE INDUSTRIES, INC.
EMZE010430
In Commercial Distribution

  • 20888277676111 ()
  • 10888277676114 ()
  • 30888277676118 ()
EMZE010430

  • Vascular access device flush/disinfection tool
SYRINGE, SWABFLUSH,5/10ML, W/SWABCAP
MEDLINE INDUSTRIES, INC.
EMZE010355
In Commercial Distribution

  • 20888277675886 ()
  • 10888277675889 ()
  • 30888277675883 ()
EMZE010355

  • Vascular access device flush/disinfection tool
SYRINGE, SWABFLUSH,10/10ML, W/SWABCAP
MEDLINE INDUSTRIES, INC.
EMZE010301
In Commercial Distribution

  • 10888277675865 ()
EMZE010301

  • Vascular access device flush/disinfection tool
No Description
MEDICAL ACTION INDUSTRIES INC.
78290
Not in Commercial Distribution

  • 20809160191115 ()
  • 10809160191118 ()


  • Vascular access device flush/disinfection tool
No Description
MEDICAL ACTION INDUSTRIES INC.
70916K
Not in Commercial Distribution

  • 20809160188757 ()
  • 10809160188750 ()


  • Vascular access device flush/disinfection tool
SwabKit®
MEDLINE INDUSTRIES, INC.
E0104-30
In Commercial Distribution

  • 20363807104307 ()
  • 10363807104300 ()
  • 00363807104303 ()

  • Kit including 2.5 mL fill in 3 mL flush syringe and SwabCap®
  • Total Volume: 2.5 Milliliter
E0104-30

  • Vascular access device flush/disinfection tool
SwabFlush®
MEDLINE INDUSTRIES, INC.
E0103-55
In Commercial Distribution

  • 20363807103553 ()
  • 10363807103556 ()
  • 00363807103559 ()

  • Total Volume: 5 Milliliter
  • 5 mL fill in 10 mL flush syringe with integrated SwabCap®
E0103-55

  • Vascular access device flush/disinfection tool
SwabFlush®
MEDLINE INDUSTRIES, INC.
E0103-35
In Commercial Distribution

  • 20363807103355 ()
  • 10363807103358 ()
  • 00363807103351 ()

  • 3 mL fill in 10 mL flush syringe with integrated SwabCap®
  • Total Volume: 3 Milliliter
E0103-35

  • Vascular access device flush/disinfection tool
SwabFlush®
MEDLINE INDUSTRIES, INC.
E0103-01
In Commercial Distribution

  • 20363807103010 ()
  • 10363807103013 ()
  • 00363807103016 ()

  • 10 mL fill in 10 mL flush syringe with integrated SwabCap®
  • Total Volume: 10 Milliliter
E0103-01

  • Vascular access device flush/disinfection tool
SwabFlush®
MEDLINE INDUSTRIES, INC.
751-600
In Commercial Distribution

  • 20363807000029 ()
  • 10363807000022 ()
  • 00363807000025 ()

  • 5 mL fill in 10 mL flush syringe with integrated SwabCap®
  • Total Volume: 5 Milliliter
751-600

  • Vascular access device flush/disinfection tool
SwabFlush®
MEDLINE INDUSTRIES, INC.
731-800
In Commercial Distribution

  • 20363807000012 ()
  • 10363807000015 ()
  • 00363807000018 ()

  • 3 mL fill in 10 mL flush syringe with integrated SwabCap®
  • Total Volume: 3 Milliliter
731-800

  • Vascular access device flush/disinfection tool
SwabFlush®
MEDLINE INDUSTRIES, INC.
711-600
In Commercial Distribution

  • 20363807000005 ()
  • 10363807000008 ()
  • 00363807000001 ()

  • 10 mL fill in 10 mL flush syringe with integrated SwabCap®
  • Total Volume: 10 Milliliter
711-600

  • Vascular access device flush/disinfection tool
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