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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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Klarity Medical - 00817355020795

25x30cm Klarity Cushion™
Klarity Medical Products, LLC
R550-M1
In Commercial Distribution

  • 00817355020795 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020788

20x25cm Klarity Cushion™
Klarity Medical Products, LLC
R550-M
In Commercial Distribution

  • 00817355020788 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020771

45x60 cm Klarity Cushion™
Klarity Medical Products, LLC
R550-L2
In Commercial Distribution

  • 00817355020771 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020764

20x25cm AccuCushion™
Klarity Medical Products, LLC
R550-L
In Commercial Distribution

  • 00817355020764 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020757

Head & Shoulder Extended Shell Cushion-Plus™ with added fill in the neck area 45x56 cm Designed to be used without a headrest
Klarity Medical Products, LLC
R550-HS2L
In Commercial Distribution

  • 00817355020757 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020740

Head & Shoulder Extended Shell Klarity Cushion™ 45x56 cm
Klarity Medical Products, LLC
R550-HS1L
In Commercial Distribution

  • 00817355020740 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020733

Head & Shoulder Shell Cushion-Plus™ with added fill in the neck area 45x50 cm Designed to be used without a headrest
Klarity Medical Products, LLC
R550-HS2
In Commercial Distribution

  • 00817355020733 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020726

Head & Shoulder Shell Cushion™ 45x50 cm
Klarity Medical Products, LLC
R550-HS1
In Commercial Distribution

  • 00817355020726 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020719

Head Only Shell Klarity Cushion™ 26x35 cm
Klarity Medical Products, LLC
R550-H1
In Commercial Distribution

  • 00817355020719 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020702

White 4-Point O-Type Pelvic Mask 42% perforation 3.2mm 46.3x48cm
Klarity Medical Products, LLC
RD901-3242
In Commercial Distribution

  • 00817355020702 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020696

Green O-Type 3-Point Pediatric Head Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RDG104-2436
In Commercial Distribution

  • 00817355020696 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020689

Green O-Type 3-Point Head Mask (with nosehole) AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RDG105-24A
In Commercial Distribution

  • 00817355020689 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020672

Green O-Type 3-Point Head Mask (with nosehole) AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RDG105-32A
In Commercial Distribution

  • 00817355020672 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020665

Light Green O-Type 3-Point Head Mask (with nosehole) 12% perforation 2.4mm
Klarity Medical Products, LLC
RDG105-2412C
In Commercial Distribution

  • 00817355020665 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020658

Green O-Type 3-Point Rounded Head Mask (with nosehole) AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RDG107-24A
In Commercial Distribution

  • 00817355020658 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020641

Green O-Type 3-Point Rounded Head Mask (with nosehole) AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RDG107-32A
In Commercial Distribution

  • 00817355020641 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020634

Klarity Green O-Type Head Mask 3.2mm, 42% Perforation, 3 Point, Rounded Neckline, With Nose Hole, for Klarity and Orfit Baseplates
Klarity Medical Products, LLC
RDG107-3242N
In Commercial Distribution

  • 00817355020634 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020627

Green O-Type 5-Point Pediatric Head & Shoulder Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RDG204-2436
In Commercial Distribution

  • 00817355020627 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020610

Green O-Type 5-Point Head & Shoulder Mask (with nosehole) AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RDG207-24A
In Commercial Distribution

  • 00817355020610 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020603

Green O-Type 5-Point Head & Shoulder Mask (with nosehole) AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RDG207-32A
In Commercial Distribution

  • 00817355020603 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020597

Klarity Green O-Type Head and Shoulder Mask 3.2mm, 42% Perforation, 5 Point, With Nose Hole, for Klarity and Orfit Baseplates
Klarity Medical Products, LLC
RDG207-3242N
In Commercial Distribution

  • 00817355020597 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020580

Light Green O-Type 5-Point Head & Shoulder Mask (with nosehole) 12% perforation 2.4mm
Klarity Medical Products, LLC
RDG207-2412C
In Commercial Distribution

  • 00817355020580 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020573

Green Large BoS Head & Shoulder Mask 42% perforation 3.2mm 48cm wide
Klarity Medical Products, LLC
RG-BSL-3242
In Commercial Distribution

  • 00817355020573 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020566

Klarity Green Head Mask for BOS, 3.2mm, 42% Perforation, Large (38cm wide) Compatible with Qfix BOS Baseplates
Klarity Medical Products, LLC
RG-BHL-3242
In Commercial Distribution

  • 00817355020566 ()


  • Patient positioning thermoplastic mould material

Level 1 - 20695085430015

No Description
ICU MEDICAL, INC.
DI-300
In Commercial Distribution

  • 50695085430016 ()
  • 20695085430015 ()


  • Convection blood/fluid warmer, high-flow

Level 1 - 20695085410017

No Description
ICU MEDICAL, INC.
DI-100
In Commercial Distribution

  • 50695085410018 ()
  • 20695085410017 ()


  • Convection blood/fluid warmer, high-flow

Meicen - 06977071937518

No Description
Guangdong Meicen Medical Equipment Co., Ltd.
/
In Commercial Distribution

  • 06977071937518 ()


  • Patient positioning thermoplastic mould material

Meicen - 06977071930908

No Description
Guangdong Meicen Medical Equipment Co., Ltd.
/
In Commercial Distribution

  • 06977071930908 ()


  • Patient positioning thermoplastic mould material

Meicen - 06977071930069

No Description
Guangdong Meicen Medical Equipment Co., Ltd.
/
In Commercial Distribution

  • 06977071930069 ()


  • Patient positioning thermoplastic mould material

Meicen - 06977071930014

No Description
Guangdong Meicen Medical Equipment Co., Ltd.
/
In Commercial Distribution

  • 06977071930014 ()


  • Patient positioning thermoplastic mould material

PUREHEAL Overlapped Compression Therapy - 06976331789102

No Description
Joicom Corporation
PH-F01
In Commercial Distribution

  • 06976331789102 ()
  • 16976331789109 ()


  • Circulating-fluid localized thermal/compression therapy system wrap

CORE DYNAMICS - 20653405045622

Insufflation Adapter
Conmed Corporation
CD320
Not in Commercial Distribution

  • 10653405045625 ()
  • 20653405045622 ()
  • 00653405045628 ()
CD320

  • Insufflation gas conditioning tubing set

Level 1 - 50695085829506

No Description
ICU MEDICAL, INC.
8002950
In Commercial Distribution

  • 50695085829506 ()


  • Convection blood/fluid warmer, high-flow

Level 1 - 50695085828264

No Description
ICU MEDICAL, INC.
H-1100-ES-115V
In Commercial Distribution

  • 50695085828264 ()


  • Convection blood/fluid warmer, high-flow

Level 1 - 50695085821098

No Description
ICU MEDICAL, INC.
HL-90-40
In Commercial Distribution

  • 50695085821098 ()


  • Convection blood/fluid warmer

Level 1 - 50695085820916

No Description
ICU MEDICAL, INC.
HL-90-SP-115
In Commercial Distribution

  • 50695085820916 ()


  • Convection blood/fluid warmer

Level 1 - 50695085820909

No Description
ICU MEDICAL, INC.
HL-90
In Commercial Distribution

  • 50695085820909 ()


  • Convection blood/fluid warmer

Level 1 - 50695085812904

No Description
ICU MEDICAL, INC.
H-1129
In Commercial Distribution

  • 50695085812904 ()


  • Convection blood/fluid warmer, high-flow

Level 1 - 50695085002404

No Description
ICU MEDICAL, INC.
HL-90-38
In Commercial Distribution

  • 50695085002404 ()


  • Convection blood/fluid warmer

Level 1 - 50695085001872

No Description
ICU MEDICAL, INC.
8002911
In Commercial Distribution

  • 50695085001872 ()


  • Convection blood/fluid warmer, high-flow

Ecolab - 50748426113748

CoreTemp Fluid Warmer
Microtek Medical LLC
CoreTemp Equipment
In Commercial Distribution

  • 50748426113748 ()
CTW5L

  • Multi-purpose warming cabinet, mobile

N/A - 03596010511560

RFB CONTROL UNIT ASSEMBLY
Smith & Nephew, Inc.
7205841F
In Commercial Distribution

  • 03596010511560 ()
7205841F

  • Insufflation gas conditioning system control unit

NA - 03596010500601

GAS WARMER IN-LINE S&N
Smith & Nephew, Inc.
7209944
In Commercial Distribution

  • 03596010500601 ()
7209944

  • Insufflation gas conditioning system control unit

HERMES - 03596010493736

INTERFACE KIT HERMES TO S&N 400 INSUF
Smith & Nephew, Inc.
7210017
In Commercial Distribution

  • 03596010493736 ()
7210017

  • Insufflation gas conditioning system control unit

NA - 03596010463807

IN-LINE GAS WARMER
Smith & Nephew, Inc.
7205868
In Commercial Distribution

  • 03596010463807 ()
7205868

  • Insufflation gas conditioning system control unit

UP & UP - 00074108400703

Conair Footbath - FB500TGg
TARGET CORPORATION
FB500TG
In Commercial Distribution

  • 00074108400703 ()


  • Foot bath

CONAIR - 00074108396860

Footbath
CONAIR CORPORATION
FB90
In Commercial Distribution

  • 00074108396860 ()


  • Foot bath

CONAIR - 00074108343666

Footbath
CONAIR CORPORATION
FB70WV16
In Commercial Distribution

  • 00074108343666 ()


  • Foot bath

CONAIR - 00074108343659

Footbath
CONAIR CORPORATION
FB70WA16
In Commercial Distribution

  • 00074108343659 ()


  • Foot bath

CONAIR - 00074108343017

Footbath
CONAIR CORPORATION
FB70WP16
In Commercial Distribution

  • 00074108343017 ()


  • Foot bath
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