FDA.reportPublic FDA data

SAFEGUARD US OPERATING, LLC

Matched from indexed company URL: Safeguard US Operating, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30082586943008258694SAFEGUARD US OPERATING, LLC1Y2026-01-0113359 Reese Blvd. E Huntersville NC US 28078

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M68980100150INTRAVENOUS INFUSION STARTER SET - The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting and securing a saline lock plus a macro-drip IV administration set.855-428-6074sales@safeguardmedical.com
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 20 - The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting and securing a saline lock plus a macro-drip IV administration set.855-428-6074sales@safeguardmedical.com
M689801101006080-110-10 Saline Lock Kit Case of 10 - The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting and securing a saline lock. The rugged, low-cube, vacuum-sealed pouch keeps the contents of the kit in prime condition until needed.1-855-428-6074sales@safeguardmedical.com
M68980110150SALINE LOCK KIT - The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting and securing a saline lock. The rugged, low-cube, vacuum-sealed pouch keeps the contents of the kit in prime condition until needed.1-855-428-6074sales@safeguardmedical.com
M68980801D160Fresh Whole Blood Donor Transfusion Set - 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.855-428-6074sales@safeguardmedical.com
M68980801R120Fresh Whole Blood Recipient Set - 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.855-428-6074sales@safeguardmedical.com
M6898143003020Maritime Boat Box - Advanced - The Maritime First Aid Family of Kits provide users with Advanced Medical products for use in medical trauma scenarios.855-428-6074sales@safeguardmedical.com
M6898250403050MEDIC ENHANCEMENT SET - The Medic Enhancement Set provides advanced capabilities for the management of battlefield trauma, setting it apart from the standard issue medical equipment. Its increased capability is specifically designed to treat the five leading causes of preventable traumatic death in combat. The Medic Enhancement Set uses MARCH™ medical gear in a comprehensive, color-coded trauma treatment system distinctly packaged with icon identifiers for ease of access and identification. It is packaged in a rugged, vacuum sealed, nylon pouch providing a layer of protection to the components until needed. RXONLY855-428-6074sales@safeguardmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1128601177623925K993120MODIFIED BLOOD RECIPIENT SETBRZ1999-11-17
1128601614707950K830509EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-BTO1983-03-29
1128601276792445K150404QiF Blood and Fluid WarmerLGZ2016-06-23
1128601303495902K133528H&H EMERGENCY CRICOTHYROTOMY KITJOH2014-07-03
1128601948454013K131877SAVE II, SAVE II BASICBTL2014-03-21
1128601209154068K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACREFMI2012-06-03
1128601671524416K102025COMBAT READY CLAMPDXC2010-08-11
1128601051836324
1128601162611511
1128601174040088
1128601259661079
1128601269187173
1128601299904415
1128601405185831
1128601429420240
1128601554663802
1128601567940773
1128601573700974
1128601650785819
1128601723197199
1128601816926118
1128601921380672
1128601940508630
1128601959918338
1128601972608866
1128601026328012
1128601101685699
1128601121985841
1128601180830743
1128601189148695
1128601561443586
1128601679031647
1128601700639094
1128601809765726
1128601857664224
1128602014327869

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXC22010-08-11
LGZ12016-06-23
JOH12014-07-03
BTL12014-03-21
FMI12012-06-03
BRZ11999-11-17
BTO11983-03-29

GUDID#

Fresh Whole Blood Donor Transfusion Set - 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

2026-05-04

Fresh Whole Blood Recipient Set - 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

2026-05-04

MEDIC ENHANCEMENT SET - The Medic Enhancement Set provides advanced capabilities for the management of battlefield trauma, setting it apart from the standard issue medical equipment. Its increased capability is specifically designed to treat the five leading causes of preventable traumatic death in combat. The Medic Enhancement Set uses MARCH™ medical gear in a comprehensive, color-coded trauma treatment system distinctly packaged with icon identifiers for ease of access and identification. It is packaged in a rugged, vacuum sealed, nylon pouch providing a layer of protection to the components until needed. RXONLY

Safeguard US Operating, LLC

2026-06-03

Mojo Multi Mission - Advanced - 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

2026-05-27

Mojo Multi Mission - Advanced - 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

2025-04-10

MARCH IFAK RESUPPLY - 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

2026-05-05

MARCH IFAK RESUPPLY - 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

2025-08-18

Fresh Whole Blood Donor Transfusion Set - 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

2025-03-04

Fresh Whole Blood Recipient Set - 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

2025-03-04

Fresh Whole Blood Recipient Set - 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

2024-12-16

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