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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ELITE 2MHZ WATERPROOF PROBE V2
NATUS NEUROLOGY INCORPORATED
X1L008
In Commercial Distribution

  • 00382830028196 ()


  • Foetal Doppler system
Natus Elite v2 Software Update
NATUS NEUROLOGY INCORPORATED
688-630000
In Commercial Distribution

  • 00382830062268 ()


  • Electromyograph
Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630100
In Commercial Distribution

  • 00382830062244 ()


  • Electromyograph
Natus Elite v2 Reader Software
NATUS NEUROLOGY INCORPORATED
828-080000
In Commercial Distribution

  • 00382830062237 ()


  • Electromyograph
Natus Elite v2 Software - Viking
NATUS NEUROLOGY INCORPORATED
828-080200
In Commercial Distribution

  • 00382830062213 ()


  • Electromyograph
Natus Elite v2 Software - Synergy
NATUS NEUROLOGY INCORPORATED
828-080100
In Commercial Distribution

  • 00382830062206 ()


  • Electromyograph
AMNIOTIC FLUID COLLECT KIT V2
MEDLINE INDUSTRIES, INC.
DYNJ59769
In Commercial Distribution

  • 10888277782747 ()
DYNJ59769

  • General surgical procedure kit, non-medicated, single-use
Somte PSG v2 lead kit
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001474 ()
7023-0003-02

  • Electrical-only medical device connection cable, reusable
Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph
AMNIOTIC FLUID COLLECT KIT V2
MEDLINE INDUSTRIES, INC.
DYNJ59769A
In Commercial Distribution

  • 10193489500929 ()
  • 40193489500920 ()
DYNJ59769A

  • General surgical procedure kit, non-medicated, single-use
AIRFIT N30I SML STPK V2
RESMED PTY LTD
63839
In Commercial Distribution

  • 00619498638390 ()
63839

  • CPAP/BPAP nasal mask, reusable
AIRFIT N30I STD STPK V2
RESMED PTY LTD
63838
In Commercial Distribution

  • 00619498638383 ()
63838

  • CPAP/BPAP nasal mask, reusable
TROCAR VERSAPORT PLUS V2 LONG
STERILMED, INC.
AUT179097P
Not in Commercial Distribution

  • 10888551013208 ()
AUT179097P

  • Laparoscopic trocar blade, reprocessed
AIRTOUCH N30I SML STPK V2
RESMED PTY LTD
62309
In Commercial Distribution

  • 00619498623099 ()
62309

  • CPAP/BPAP nasal mask, reusable
AIRTOUCH N30I STD STPK V2
RESMED PTY LTD
62308
In Commercial Distribution

  • 00619498623082 ()
62308

  • CPAP/BPAP nasal mask, reusable
SERUM DRUGS LEVEL 2 V2
UTAK LABORATORIES, INC.
DRUGS 2 V2 S SH
In Commercial Distribution

  • B800DRUGS2V2SSH5 ()
  • B800DRUGS2V2SSH0 ()

  • Total Volume: 3 Milliliter
DRUGS 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
SERUM DRUGS LEVEL 1 V2
UTAK LABORATORIES, INC.
DRUGS 1 V2 S SH
In Commercial Distribution

  • B800DRUGS1V2SSH5 ()
  • B800DRUGS1V2SSH0 ()

  • Total Volume: 3 Milliliter
DRUGS 1 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE POSITIVE V2
UTAK LABORATORIES, INC.
DAU POS V2 F UPMC
In Commercial Distribution

  • B800DAUPOSV2FUPMC5 ()
  • B800DAUPOSV2FUPMC0 ()

  • Total Volume: 10 Milliliter
DAU POS V2 F UPMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE MID V2
UTAK LABORATORIES, INC.
DAU MID V2 F PG
In Commercial Distribution

  • B800DAUMIDV2FPG5 ()
  • B800DAUMIDV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU MID V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LOW V2
UTAK LABORATORIES, INC.
DAU LOW V2 F PG
In Commercial Distribution

  • B800DAULOWV2FPG5 ()
  • B800DAULOWV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU LOW V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE HIGH V2
UTAK LABORATORIES, INC.
DAU HIGH V2 F PG
In Commercial Distribution

  • B800DAUHIGHV2FPG5 ()
  • B800DAUHIGHV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU HIGH V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU B LEVEL 2 V2
UTAK LABORATORIES, INC.
DAU B 2 V2 F IHL
In Commercial Distribution

  • B800DAUB2V2FIHL5 ()
  • B800DAUB2V2FIHL0 ()

  • Total Volume: 10 Milliliter
DAU B 2 V2 F IHL

  • Multiple drugs of abuse IVD, control
DAU B LEVEL 1 V2
UTAK LABORATORIES, INC.
DAU B 1 V2 F IHL
In Commercial Distribution

  • B800DAUB1V2FIHL5 ()
  • B800DAUB1V2FIHL0 ()

  • Total Volume: 10 Milliliter
DAU B 1 V2 F IHL

  • Multiple drugs of abuse IVD, control
CLOZAPINE 50 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 50 V2 UCI
In Commercial Distribution

  • B800CLOZ50V2UCI5 ()
  • B800CLOZ50V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 50 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 500 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 500 V2 UCI
In Commercial Distribution

  • B800CLOZ500V2UCI5 ()
  • B800CLOZ500V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 500 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 3 V2
UTAK LABORATORIES, INC.
BUP+ 3 V2 U F MAYO
In Commercial Distribution

  • B800BUP3V2UFMAYO5 ()
  • B800BUP3V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 3 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U KP
In Commercial Distribution

  • B800BUP2V2UKP5 ()
  • B800BUP2V2UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U KP

  • Multiple drugs of abuse IVD, control
ANABASINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
ANAB+ 2 V2 U LC
In Commercial Distribution

  • B800ANAB2V2ULC5 ()
  • B800ANAB2V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 2 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANABASINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
ANAB+ 1 V2 U LC
In Commercial Distribution

  • B800ANAB1V2ULC5 ()
  • B800ANAB1V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 1 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
AMITRIPTYLINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
AMIT+ 2 V2 S SH
In Commercial Distribution

  • B800AMIT2V2SSH5 ()
  • B800AMIT2V2SSH0 ()

  • Total Volume: 3 Milliliter
AMIT+ 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
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