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
M68981601030Rant Strategies K9 Trauma Kit - A trauma kit designed for trauma treatment of K9s. These kits include interventions to address immediate threats to life from massive hemorrhage, respiratory effects from chest trauma, and lacerations.855-428-6074sales@safeguardmedical.com
M6898723101011Bleeding Control Kit - 1 TMT® Tourniquet 1 Hemostatic gauze (OTC) 2 Vented chest seal 1 Pre-Lubricated nasal airway 1 Compression dressing 1 Pair Exam gloves 1 Instruction guide855-428-6074fulfillment@combatmedical.com
M689HHCWS01040Compact Wound Seal Kit - Compact Wound Seal Kit is a hydrogel-based dressing non-vented seal used by emergency medical personnel in the Battlefield/or Pre-hospital. Intended for use on adult patients who have suffered an open wound to prevent the escape of air to retain air circulation.855-428-6074sales@safeguardmedical.com
M689HHMTG01020MiniTAC Gauze - The mini-TAC Gauze is apart the TACGauze Family of Products are to be used by emergency medical personnel in the Battle Field/or Pre-hospital. This smaller version of the TACGauze is a sterile non-woven cotton gauze.855-428-6074fulfillment@combatmedical.com
M689HVPIK060H-Vent Vented Chest Seal - H*VENT Penetrating Injury Kit is apart of the Sterile Wound Seal Family of Products to be used by emergency medical personnel in the battlefield or pre-hospital setting. Provides a fast application for sealing wounds quickly to stop external bleeding.855-428-6074sales@safeguardmedical.com
M689TOCSEA030Curaplex TOCS - Curaplex TOCS is a hydrogel-based dressing non-vented seal used by emergency medical personnel in the Battlefield/or Pre-hospital. Intended for use on adult patients who have suffered an open wound to prevent the escape of air to retain air circulation.855-428-6074sales@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#

200 records. Showing 1-40. Next