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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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KIATO PLUS Sterile Carbon steel Surgical Blade box of 100 size 11. Sterilized by Gamma irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
11
In Commercial Distribution

  • 28902895180118 ()
  • 08902895180114 ()
18011

  • Manual scalpel blade, single-use
Kiato Sterile Disposable Scalpel Stainless Steel box of 10 size 11. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
11
In Commercial Distribution

  • 28902895148118 ()
  • 08902895148114 ()
14811

  • Scalpel, single-use
KIATO Plus Sterile Safety Scalpel Stainless Steel Box of 10 size 11. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
11
In Commercial Distribution

  • 28902895129117 ()
  • 08902895129113 ()
12911

  • Scalpel, single-use
KIATO PLUS Sterile Stainless Steel Surgical Blade box of 100 size 11. Sterilized by Gamma Irradiation
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
11
In Commercial Distribution

  • 28902895181115 ()
  • 08902895181111 ()
18111

  • Manual scalpel blade, single-use
KIATO sterile CE Carbon steel surgical blade Box of 100 size 11. Sterilized by Gamma Irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
11
In Commercial Distribution

  • 28902895111112 ()
  • 08902895111118 ()
11111

  • Manual scalpel blade, single-use
RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency Chest Wall Oscillation (HFCWO) device that maximizes the use of modern technologies and materials to produce a more comfortable, flexible and effective therapy delivery system.
RESPINNOVATION
11
In Commercial Distribution

  • 03760251321107 ()


  • Chest-oscillation airway secretion-clearing system
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 3 gallon twin pack sharps disposal ship back system (Includes two 3 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
11
In Commercial Distribution

  • 10853022008083 ()
  • 00853022008086 ()

  • Total Volume: 3.0 Gallon
40023

  • Sharps container
Sample Collection Kit
Biodesix, Inc.
11
In Commercial Distribution

  • G29251110 ()
51

  • Blood collection set, invasive
Tinted Glow Powder
JBC and Company
11
In Commercial Distribution

  • D85111 ()
11

  • Dental appliance fabrication material, resin
The Mojo® Direct Action Aid Bag strikes the balance between smaller Combat Lifesaver bags and bulkier advanced care bags. This ultra low profile, multi-mission medical bag is designed for use in close quarters and vehicle environments. The pockets, flaps, pouches and multi-loop retention system allow for maximum configuration options for a variety of patrol, assault, rescue and vehicle-based missions.
Safeguard US Operating, LLC
11
In Commercial Distribution

  • M68984497110 ()
84-497

  • First aid kit, non-medicated, single-use
The Mojo® Direct Action Aid Bag strikes the balance between smaller Combat Lifesaver bags and bulkier advanced care bags. This ultra low profile, multi-mission medical bag is designed for use in close quarters and vehicle environments. The pockets, flaps, pouches and multi-loop retention system allow for maximum configuration options for a variety of patrol, assault, rescue and vehicle-based missions. Inside the Direct Action Aid Bag are clear, removable pockets that allow for quick, organized treatments using medical gear in a user-friendly, color-coded trauma treatment system distinctly packaged with icon identifiers to treat the five preventable causes of death in combat
Safeguard US Operating, LLC
11
In Commercial Distribution

  • M68984495010110 ()
84-495-01

  • First aid kit, non-medicated, single-use
The Mojo® Multi-Mission Aid Bag is two medic bags in one. A main bag with 2,645 in3 of interior space designed and stocked to carry component resupply or to provide sustainment of multiple casualties for extended periods. The kit also includes a zip-off, low profile assault bag with 595 in3 of interior space that is configured and stocked for trauma and immediate tactical care. Assault, tactical or sustained care, together these two bags provide the Medic multiple options for every possible mission.
Safeguard US Operating, LLC
11
In Commercial Distribution

  • M68984443110 ()
84-443

  • First aid kit, non-medicated, single-use
The Mojo® Multi-Mission Aid Bag is two medic bags in one. A main bag with 2,645 in3 of interior space designed and stocked to carry component resupply or to provide sustainment of multiple casualties for extended periods. The kit also includes a zip-off, low profile assault bag with 595 in3 of interior space that is configured and stocked for trauma and immediate tactical care. Assault, tactical or sustained care, together these two bags provide the Medic multiple options for every possible mission.
Safeguard US Operating, LLC
11
In Commercial Distribution

  • M68984441110 ()
84-441

  • First aid kit, non-medicated, single-use
The MARCH™ IFAK Resupply bundle is intended to be used as resupply for the US Army standard IFAK or similar commercial applications. Using the combat-proven practice of kit organization and standardization, the MARCH™ IFAK Resupply is designed to be used under the most adverse conditions. It uses MARCH™ medical gear in a color-coded trauma treatment system to treat the five leading causes of preventable death on the battlefield. It comes with quick reference cards to complete the system.
Safeguard US Operating, LLC
11
In Commercial Distribution

  • M6898130301110 ()
81-303-01

  • First aid kit, non-medicated, single-use
ADVANCED LTOWB COLLECTION SET Constricting Band (18" x 1") 1 ea Gauze Sponge 2 ea Safety IV Cath 16G x 1.25" 2 ea Prevahex Transparent Dressing (4" x 4.75") 2 ea Blood Collection Bag 1 ea Gloves 1 pr Chlorhexidine Swab 2 ea Kelly Clamp 1 ea Needle Port 2 ea Beaded Cable Tie 1 ea Nylon Cord (10") 1 ea ASBP 572 1 ea Blood Bag Label 1 ea Valkyrie TCCC Card 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
11
In Commercial Distribution

  • M68980820110 ()
80-820

  • Blood transfusion set, non-exchange
he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient information, screen for ABO/Rh compatibility and transfuse fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
11
In Commercial Distribution

  • M68980801R110 ()
80-801-R

  • Blood transfusion set, non-exchange
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution

  • M68980801D110 ()
80-801-D

  • Blood donor set, single-pack
18 GA. Catheter 1 ea 20 GA. Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea Needle Free Valve w/ Luer Lock 1 ea Constricting Band 1 ea Transparent Film Dressing 1 ea Sterile Gauze Pad 2 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution

  • M68980110110 ()
80-110

  • Wound irrigation cannula
18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea IV Administration Set 1 ea Needle Free Valve with Luer Lock 1 ea Constricting Band 1 ea IV Catheter Dressing 1ea Transparent Film Dressing 1 ea Adhesive Bandage 1 ea 2"x2" Gauze Pad (2 pack) 1 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution

  • M68980100110 ()
80-100

  • Intraosseous infusion kit
NOVA 11 Na+, K+, Li+, Hct
NOVA BIOMEDICAL CORPORATION
11
In Commercial Distribution

  • 00385480156493 ()
15649

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
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