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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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KermaX-plus - EIBA120131160

KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
2
In Commercial Distribution

  • EIBA120131161 ()
  • EIBA120131160 ()
120-131 MIC CAN

  • Diagnostic x-ray system quality assurance device

KermaX-plus - EIBA120131120

KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
2
In Commercial Distribution

  • EIBA120131121 ()
  • EIBA120131120 ()
120-131 HS/RS485

  • Diagnostic x-ray system quality assurance device

KermaX-plus - EIBA12013030

KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
2
In Commercial Distribution

  • EIBA12013031 ()
  • EIBA12013030 ()
120-130 CAN

  • Diagnostic x-ray system quality assurance device

Fresh Whole Blood Recipient Set - M68980801R020

Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient. Product Description In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set.
Safeguard US Operating, LLC
2
Not in Commercial Distribution

  • M68980801R020 ()
80-801-R

  • Blood transfusion set, non-exchange

Fresh Whole Blood Donor Transfusion Set - M68980801D020

Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Donor Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood Donor in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) DONOR SET- PN: 80-801-D is: • Assembled in GMP facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. DONOR SET- PN: 80-801-D • Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea • Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea • Blood Tube- Pearl Top 3 ea Chloraprep Swabstick 1 ea • Blood Tube- Gold Top 2 ea 5.5” Kelly Clamp 1 ea • Blood Tube- Lavender Top 1 ea Nylon Cord (10”) 1 ea • Blood Collection Needle 1 ea
Safeguard US Operating, LLC
2
Not in Commercial Distribution

  • M68980801D020 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Transfusion Set - M68980801020

Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient. Product Description In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) • Donor and recipient specific modules • Shelf life: 12 months • Made in USA Clinical Benefit • Assembled in FDA registered facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing.
Safeguard US Operating, LLC
2
Not in Commercial Distribution

80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack

Nasal Trumpet - M68911112020

1ea - Sterile, 28 Fr Nasopharyngeal Airway, 1ea - Surgical Lubricant
Safeguard US Operating, LLC
2
Not in Commercial Distribution

  • M68911112020 ()
11-112

  • Laryngeal mask airway, single-use

Eye Shield - M68906200020

1ea - 2.5" x 3.25", aluminum eye shield w/garter
Safeguard US Operating, LLC
2
Not in Commercial Distribution

  • M68906200020 ()
06-200

  • Eye patch

KermaX-plus - EIBA120131320

KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
2
In Commercial Distribution

  • EIBA120131321 ()
  • EIBA120131320 ()
120-131 MICRO

  • Diagnostic x-ray system quality assurance device

KermaX-plus - EIBA120131260

KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
2
In Commercial Distribution

  • EIBA120131261 ()
  • EIBA120131260 ()
120-131ZKCANO

  • Diagnostic x-ray system quality assurance device
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