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SAFEGUARD US OPERATING, LLC

Last updated September 17, 2026

Information

Country: US
Address: 13359 Reese Blvd. E, Huntersville, NC, 28078
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008258694
DUNS Number: —

Catalogue (387)

Page 1 of 8

Device	Model / Reference	Registries	Class	Status
Low Titer Type O Donor Collection Set	03	FDA UDI	Class II	Active
Hypothermia Management Set - Bag (GR) and Grid (8 cell)	01	FDA UDI	Class I	Active
Saline Lock Kit	13	FDA UDI	Class II	Active
H-Vent	01	FDA UDI	Class I	Active
Nasopharyngeal Airway 30FR	1	FDA UDI	N/A	Active
GO IO Intraosseous Start Kit 12/Case	03	FDA UDI	Class II	Active
Wound Seal Kit	04	FDA UDI	Class I	Active
Mojo Initial Responder Bag - Basic	01	FDA UDI	Class I	Active
Safeguard Medical	01	FDA UDI	Class I	Active
Cravat	04	FDA UDI	Class I	Unknown
Chest Tube Insertion Kit - Non Trade Compliant	02	FDA UDI	Class I	Active
Mojo Combat Lifesaver Bag - Advanced	05	FDA UDI	Class I	Unknown
SAVeII+ Starter Bundle, 10-Patient – Basic	01	FDA UDI	Class II	Active
HAWK Advanced Hypothermia Management Set	01	FDA UDI	Class I	Unknown
Mojo Crisis Responder - Advanced	02	FDA UDI	Class I	Active
SAVeII+ Starter Bundle, 3-Patient – Basic	01	FDA UDI	Class II	Active
Mojo Direct Action - Advanced	11	FDA UDI	Class I	Active
Medical Trauma Kit Individual Trauma Kit OTC	1	FDA UDI	Class I	Active
Mojo RTF Carrier - Advanced	02	FDA UDI	Class I	Active
Mojo Crisis Responder - Basic	01	FDA UDI	Class I	Active
Fresh Whole Blood Transfusion Set	2	FDA UDI	Class II	Unknown
Micro Trauma Kit - Basic	01	FDA UDI	Class I	Active
TMT Rigid Holster Kit w/ Malice Clip Tactical Taylor Back Attachment	01	FDA UDI	Class I	Active
Rolled Gauze	06	FDA UDI	Class I	Active
Chest Wound Seal Kit	04	FDA UDI	Class I	Active
Battle Wrap	5	FDA UDI	Class I	Unknown
Low Titer Type O FWB Transfusion Set	01	FDA UDI	Class II	Unknown
Medical Trauma Kit Station (INTERMEDIATE)	03	FDA UDI	Class I	Active
High Threat - Advanced	02	FDA UDI	Class I	Unknown
Mojo RTF Carrier - Advanced	03	FDA UDI	Class I	Active
Valkyrie LTOWB Collection Set	02	FDA UDI	Class II	Unknown
Nasal Trumpet	02	FDA UDI	Class I	Active
Pocket Trauma Kit Intermediate	01	FDA UDI	Class I	Active
Medic Enhancement Resupply	00	FDA UDI	Class II	Unknown
Individual Trauma Kit - Advanced	01	FDA UDI	Class I	Active
Mojo Vehicle Medical Bag - Intermediate	03	FDA UDI	Class I	Active
Mojo Combat Lifesaver Bag - Intermediate	03	FDA UDI	Class I	Unknown
Advanced Trauma Kit	01	FDA UDI	Class I	Active
H-Bandage Flat Fold	01	FDA UDI	Class I	Active
Hypothermia Management Set	02	FDA UDI	Class I	Active
Sentinel Chest Seal	03	FDA UDI	Class I	Unknown
Battle Bandage	06	FDA UDI	Class I	Active
Pocket Bleeder Kit Intermediate	03	FDA UDI	Class I	Active
Nasal Trumpet	03	FDA UDI	Class I	Unknown
Nasal Trumpet	2	FDA UDI	Class I	Unknown
Individual Trauma Kit - Basic	05	FDA UDI	Class I	Active
Emergency Trauma Kit	01	FDA UDI	Class I	Active
Low Titer Type O Donor Collection Set	02	FDA UDI	Class II	Unknown
Mojo Vehicle Rescue Bag - Intermediate	01	FDA UDI	Class I	Active
HAWK Warming Grid	02	FDA UDI	Class I	Unknown

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 27, 2024	Z-3183-2024	—	open, classified	Incorrect expiration date.
Aug 27, 2024	Z-3181-2024	—	open, classified	Incorrect expiration date.
Aug 27, 2024	Z-3182-2024	—	open, classified	Incorrect expiration date.