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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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ADVIA Centaur® iPTH MCM - 00630414579177

PTH Intact Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492373
In Commercial Distribution

  • 00630414579177 ()
10492373

  • Parathyroid hormone (PTH) IVD, control

ADVIA Centaur® Systems QC iPTH - 00630414579184

PTH Intact - CENTAUR - CTL - 3x2x2mL
Siemens Healthcare Diagnostics Inc.
10492378
In Commercial Distribution

  • 00630414579184 ()
10492378

  • Parathyroid hormone (PTH) IVD, control

Alinity - 00380740136208

Alinity i Intact PTH Controls
Abbott GmbH
08P3110
Not in Commercial Distribution

  • 00380740136208 ()
08P3110

  • Parathyroid hormone (PTH) IVD, control

Alinity - 00380740131586

Alinity i Intact PTH Calibrators
Abbott GmbH
08P3101
Not in Commercial Distribution

  • 00380740131586 ()
08P3101

  • Parathyroid hormone (PTH) IVD, calibrator

Alinity - 00380740121860

Alinity i Progesterone Controls
ABBOTT IRELAND
08P3610
In Commercial Distribution

  • 00380740121860 ()
08P3610

  • Progesterone IVD, control

Alinity - 00380740121853

Alinity i Progesterone Calibrators
ABBOTT IRELAND
08P3601
In Commercial Distribution

  • 00380740121853 ()
08P3601

  • Progesterone IVD, calibrator

Alinity - 00380740121563

Alinity i Prolactin Controls
ABBOTT IRELAND
07P6610
In Commercial Distribution

  • 00380740121563 ()
07P6610

  • Prolactin IVD, control

Alinity - 00380740121556

Alinity i Prolactin Calibrators
ABBOTT IRELAND
07P6601
In Commercial Distribution

  • 00380740121556 ()
07P6601

  • Prolactin IVD, calibrator

Alinity - 00380740193829

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6110
In Commercial Distribution

  • 00380740193829 ()
06S6110

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740193805

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6101
In Commercial Distribution

  • 00380740193805 ()
06S6101

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740193744

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

ARCHITECT - 00380740193720

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6001
In Commercial Distribution

  • 00380740193720 ()
06S6001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740175481

ARCHITECT STAT High Sensitivity Troponin-I Controls
ABBOTT IRELAND
02R9810
In Commercial Distribution

  • 00380740175481 ()
02R9810

  • Troponin I IVD, control

Alinity - 00380740165482

Alinity i STAT CK-MB Calibrators
Abbott Ireland Diagnostics
04V3801
In Commercial Distribution

  • 00380740165482 ()
04V3801

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Fresh Whole Blood Donor Transfusion Set - M68980801D150

The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of 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
15
In Commercial Distribution

  • M68980801D150 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D140

The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of 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
14
In Commercial Distribution

  • M68980801D140 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D110

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

Fresh Whole Blood Donor Transfusion Set - M68980801D090

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 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
09
In Commercial Distribution

  • M68980801D090 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D080

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 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
8
Not in Commercial Distribution

  • M68980801D080 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D070

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 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
7
Not in Commercial Distribution

  • M68980801D070 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D040

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea Blood Tube- Lavender Top 4 ea Chlorhexidine Swab 1 ea Blood Tube- Red Top 2 ea 5.5” Kelly Clamp 1 ea Blood Collection Needle 21gx1.25" 1 ea Nylon Cord (10”) 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
Safeguard US Operating, LLC
4
Not in Commercial Distribution

  • M68980801D040 ()
80-801-D

  • Blood donor set, single-pack

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 Donor Transfusion Set - M68980801D0

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
1
Not in Commercial Distribution

  • M68980801D0 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Transfusion Set - M68980801060

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.
Safeguard US Operating, LLC
06
In Commercial Distribution

  • M68980801060 ()
80-801

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

Fresh Whole Blood Transfusion Set - M68980801050

FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
5
In Commercial Distribution

  • M68980801050 ()
80-801

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

Fresh Whole Blood Transfusion Set - M68980801040

FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
4
Not in Commercial Distribution

  • M68980801040 ()
80-801

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

Fresh Whole Blood Transfusion Set - M68980801030

FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
3
Not in Commercial Distribution

  • M68980801030 ()
80-801

  • Blood transfusion set, non-exchange
  • 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

Fresh Whole Blood Transfusion Set - M689808010

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. Specifications • NSN: 6515-01-657-4750 • PN: 80-801 • Single-use • 12-month Shelf Life o Does not contain natural rubber latex • Available Direct and GSA • 100% TAA Compliant • Made i
Safeguard US Operating, LLC
1
Not in Commercial Distribution

  • M689808010 ()
80-801

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

NA - 07332414075828

SP 418 (9L Bag) Accessory Drain Bag
GAMBRO DASCO SPA
6033765
In Commercial Distribution

  • 37332414075829 ()
  • 07332414075828 ()

  • Total Volume: 9 Liter
107650

  • Extracorporeal circuit waste bag
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