Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008258694

FEI Number

3008258694

Entity Name

SAFEGUARD US OPERATING, LLC

City/State/Country

Huntersville, NC, US

Establishment Address

13359 Reese Blvd. E, Huntersville, NC 28078, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Safeguard US Holdco, Inc. (Owner Number: 10031323)

Owner / Operator Contact Address

13359 Reese Blvd. E, Huntersville, NC 28078, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Safeguard GO IO Safeguard - HH Surgical Airway APE SAVe II+ Universal Splint Sentinel Chest Seal Safeguard Warrior Extreme Individual Personal Protective Equipment Safeguard - chest tube insertion Safeguard - Advanced Hypothermia Mgt HAWK DART Safeguard Safeguard - emergency blanket Safeguard HAWK Mgt Set SWAT-T Safeguard Prometheus Safeguard - chest seals SAVe I conversion kit Safeguard Medical SAVe II+ Safeguard MOJO EMT MOJO Safeguard TMT Holster MARCH Bleeding Control Maritime Safeguard - Public Safety Safeguard Cravat BDX Safeguard Battle Bandage Battle Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-03-01
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2022-08-30
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2022-07-20
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2022-08-22
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2026-04-07
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2025-09-30
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-05-19
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2020-07-21
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2020-07-21
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2025-06-12
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2017-12-01
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-02-20
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-06-05
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-03-28
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2019-12-09
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2018-01-24
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2022-03-01
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2018-10-03
OGP	Cricothyrotomy Kit	Anesthesiology	Class 2	868.5800	2022-08-30
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2023-04-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2017-11-27
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2017-01-24
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2016-03-29
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2015-12-10

Official Correspondent

Kimberly Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Safeguard US Holdco, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22
K142296	Covidien	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	2015-02-24
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008258694. Last updated year: 2026. Please use registration number 3008258694 when referencing this establishment in official correspondence.