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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Acessa Pad Cable, Reusable, connects to the Acessa ProVu Console Legacy DI #854763006072
ACESSA HEALTH INC.
4300
In Commercial Distribution

  • 00854763006119 ()


  • Radio-frequency ablation system
Sterile Disposable Guidance Ultrasound Transducer Sleeve
HALT MEDICAL, INC
5500
In Commercial Distribution

  • 00854763006058 ()
5500

  • Radio-frequency ablation system
Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline supply line with spiked end.
AEGEA MEDICAL INC.
DDK-16-050
In Commercial Distribution

  • 00857379006030 ()
DDK-16-050

  • Water vapour endometrial-ablation applicator
No Description
Telesair, Inc.
RHFG303
In Commercial Distribution

  • 00850057298000 ()


  • Professional high-flow respiratory unit, humidifying, manual
No Description
Dfine, Inc.
3192
Not in Commercial Distribution

  • 00850696006691 ()
3192

  • Radio-frequency ablation system
No Description
Dfine, Inc.
3544
Not in Commercial Distribution

  • 00850696006684 ()
3544

  • Radio-frequency ablation system
blister tray packaging
Dfine, Inc.
RF-1015L-01
Not in Commercial Distribution

  • 00850696006677 ()
RF-1015L-01

  • Radio-frequency ablation system
blister tray packaging
Dfine, Inc.
RF-1015S-01
Not in Commercial Distribution

  • 00850696006660 ()
RF-1015S-01

  • Radio-frequency ablation system
blister tray packaging
Dfine, Inc.
RF-0510L-01
Not in Commercial Distribution

  • 00850696006653 ()
RF-0510L-01

  • Radio-frequency ablation system
blister tray packaging
Dfine, Inc.
RF-0510S-01
Not in Commercial Distribution

  • 00850696006646 ()
RF-0510S-01

  • Radio-frequency ablation system
ala carte packaging
Dfine, Inc.
RF-1015L-01
Not in Commercial Distribution

  • 00850696006271 ()
RF-1015L-01

  • Radio-frequency ablation system
ala carte packaging
Dfine, Inc.
RF-0510S-01
Not in Commercial Distribution

  • 00850696006264 ()
RF-0510S-01

  • Radio-frequency ablation system
ala carte packaging
Dfine, Inc.
RF-0510L-01
Not in Commercial Distribution

  • 00850696006257 ()
RF-0510L-01

  • Radio-frequency ablation system
ala carte packaging
Dfine, Inc.
RF-1015S-01
Not in Commercial Distribution

  • 00850696006240 ()
RF-1015S-01

  • Radio-frequency ablation system
No Description
Dfine, Inc.
STR-0510L
Not in Commercial Distribution

  • 00850696006011 ()
STR-0510L

  • Radio-frequency ablation system
No Description
Dfine, Inc.
STR-1015L
Not in Commercial Distribution

  • 00850696006004 ()
STR-1015L

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
In Commercial Distribution

  • 10860036000569 ()
  • 00860036000562 ()
  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
In Commercial Distribution

  • 10860036000552 ()
  • 00860036000555 ()
  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
In Commercial Distribution

  • 10860036000545 ()
  • 00860036000548 ()
  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system
Water Bottle Adapter and Disposable Patient Circuit High Flow
VAPOTHERM, INC.
PF-DPC-High-WBA
In Commercial Distribution

  • 10841737102509 ()
  • 00841737102502 ()


  • Professional high-flow respiratory unit, humidifying, manual
Water Bottle Adapter and Disposable Patient Circuit Low Flow
VAPOTHERM, INC.
PF-DPC-Low-WBA
In Commercial Distribution

  • 10841737102493 ()
  • 00841737102496 ()


  • Professional high-flow respiratory unit, humidifying, manual
AAA-1
VAPOTHERM, INC.
AAA-1
In Commercial Distribution

  • 10841737100758 ()
  • 00841737100751 ()


  • Professional high-flow respiratory unit, humidifying, manual
Water Bottle Adapter
VAPOTHERM, INC.
PF-WBA
In Commercial Distribution

  • 10841737100734 ()
  • 00841737100737 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow
VAPOTHERM, INC.
PF-UNIT
In Commercial Distribution

  • 00841737100140 ()


  • Professional high-flow respiratory unit, humidifying, manual
Nitric Oxide Disposable Patient Circuit, Low Flow
VAPOTHERM, INC.
PF-NODPC-LOW
In Commercial Distribution

  • 10841737100116 ()
  • 00841737100119 ()


  • Professional high-flow respiratory unit, humidifying, manual
Nitric Oxide Disposable Patient Circuit, High Flow
VAPOTHERM, INC.
PF-NODPC-HIGH
In Commercial Distribution

  • 00841737100102 ()
  • 10841737100109 ()


  • Professional high-flow respiratory unit, humidifying, manual
Disposable Patient Circuit, Low Flow
VAPOTHERM, INC.
PF-DPC-LOW
In Commercial Distribution

  • 10841737100093 ()
  • 00841737100096 ()


  • Professional high-flow respiratory unit, humidifying, manual
Disposable Patient Circuit, High Flow
VAPOTHERM, INC.
PF-DPC-HIGH
In Commercial Distribution

  • 10841737100086 ()
  • 00841737100089 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT-DPC-BR
VAPOTHERM, INC.
HVT-DPC-BR
In Commercial Distribution

  • 10841737105753 ()
  • 00841737105756 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT-BAT-BR
VAPOTHERM, INC.
HVT-BAT-BR
In Commercial Distribution

  • 00841737105749 ()


  • Professional high-flow respiratory unit, humidifying, manual
HPF-TA-22-BR
VAPOTHERM, INC.
HPF-TA-22-BR
In Commercial Distribution

  • 00841737105725 ()
  • 10841737105722 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Unit, VTU, OUS, Brazil Version
VAPOTHERM, INC.
HVT20-UNIT-VTU-BR
In Commercial Distribution

  • 00841737105718 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 UKIT, Brazil Version
VAPOTHERM, INC.
HVT-UKIT-BR
In Commercial Distribution

  • 00841737105701 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 VTU OUS, Brazil Version
VAPOTHERM, INC.
HVT-VTU-OUS-BR
In Commercial Distribution

  • 00841737105695 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT20-MAS-FLM
VAPOTHERM, INC.
HVT20-MAS-FLM
In Commercial Distribution

  • 00841737105688 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT20-NEL-FLM
VAPOTHERM, INC.
HVT20-NEL-FLM
In Commercial Distribution

  • 00841737105671 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT20-UNIT-FLM
VAPOTHERM, INC.
HVT20-UNIT-FLM
In Commercial Distribution

  • 00841737105664 ()


  • Professional high-flow respiratory unit, humidifying, manual
PF Plus Compliant Version, Floor Model Unit
VAPOTHERM, INC.
PF-C-PLUS-FLM
In Commercial Distribution

  • 00841737105657 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, German Version
VAPOTHERM, INC.
HVT-UKIT-DE
In Commercial Distribution

  • 00841737105640 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, Canada Version
VAPOTHERM, INC.
HVT-UKIT-CA
In Commercial Distribution

  • 00841737105633 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 DPC-WBA Bundled SKU
VAPOTHERM, INC.
HVT-DPC-WBA
In Commercial Distribution

  • 10841737105623 ()
  • 00841737105626 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 ADPC-WBA Bundled SKU
VAPOTHERM, INC.
HVT-ADPC-WBA
In Commercial Distribution

  • 10841737105616 ()
  • 00841737105619 ()


  • Professional high-flow respiratory unit, humidifying, manual
Air Filter Cover
VAPOTHERM, INC.
43000742
In Commercial Distribution

  • 00841737105602 ()


  • Professional high-flow respiratory unit, humidifying, manual
Carabiner
VAPOTHERM, INC.
43000741
In Commercial Distribution

  • 00841737105596 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 ADPC, High Flow
VAPOTHERM, INC.
HVT-ADPC-HIGH
In Commercial Distribution

  • 10841737105586 ()
  • 00841737105589 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 ADPC, Low Flow
VAPOTHERM, INC.
HVT-ADPC-LOW
In Commercial Distribution

  • 10841737105579 ()
  • 00841737105572 ()


  • Professional high-flow respiratory unit, humidifying, manual
Tubing Adapter for HVT/PF, 22mm
VAPOTHERM, INC.
HPF-TA-22
In Commercial Distribution

  • 10841737105562 ()
  • 00841737105565 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, Australia Version
VAPOTHERM, INC.
HVT-UKIT-AU
In Commercial Distribution

  • 00841737105541 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, Argentina Version
VAPOTHERM, INC.
HVT-UKIT-AR
In Commercial Distribution

  • 00841737105534 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT-UKIT-DISS-EU
VAPOTHERM, INC.
HVT-UKIT-DISS-EU
In Commercial Distribution

  • 00841737105510 ()


  • Professional high-flow respiratory unit, humidifying, manual
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