Safeguard US Operating, LLC

Address:13827 Carowinds Blvd,Charlotte,NC,28273,US

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Premarket Exempt
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- Catalog Number : 59-320

Device Description : HAWK Advanced Hypothermia Management Set1 ea - 23" x 20" HAWK Waring Grid w/ abs HAWK Advanced Hypothermia Management Set1 ea - 23" x 20" HAWK Waring Grid w/ absorbent pad; 1 ea - 32" x 81" Thermal Patient Litter SystemWarning: Not for use on infants. Do not separate the HAWK Warming Grid from the absorbent pad. Device has the potential to produce burns. Always monitor and reassess during use.

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : KME, IMD

Prescription Use : No

Device Count : 1

- Catalog Number : 80-081

Device Description : The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solutio The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous vascular access. The T.A.L.O.N.™ provides combat lifesavers and combat medics with rapid and accurate, manual IO access to all seven sites. Product DescriptionThe T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous (IO) vascular access. The T.A.L.O.N. allows providers rapid and accurate IO access to all seven sites. The T.A.L.O.N. delivers life-saving fluids and medications rapidly and accurately for casualty resuscitation. T.A.L.O.N. is the first and only FDA-cleared manual IO device with 7-site access: sternum, bilateral proximal humerus, bilateral proximal tibia, and bilateral distal tibia. A single T.A.L.O.N. provides IO access—there are no powered tools or multiple needles necessary and no special removal tool is required. Simple step-by-step instructions and minimal insertion pressure is required to ensure that combat lifesavers and medics can use the T.A.L.O.N. effectively with proper training. Capabilities• 7-Site IO Vascular Access • Simple Delivery of life-saving fluids and medication • Rapid Resuscitation Product Attributes• Access to any IO site with one manual device• No need for additional devices, multiple needles or special removal tools• Meets CoTCCC recommendations for IO devicesClinical Benefits• First and only FDA-cleared manual IO device with 7-site access: o Sternumo Bilateral proximal humeruso Bilateral proximal tibiao Bilateral distal tibia• Delivers fluids and medications rapidly and safely

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-081

Device Description : The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solutio The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous vascular access. The T.A.L.O.N.™ provides combat lifesavers and combat medics with rapid and accurate, manual IO access to all seven sites. Product DescriptionThe T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous (IO) vascular access. The T.A.L.O.N. allows providers rapid and accurate IO access to all seven sites. The T.A.L.O.N. delivers life-saving fluids and medications rapidly and accurately for casualty resuscitation. T.A.L.O.N. is the first and only FDA-cleared manual IO device with 7-site access: sternum, bilateral proximal humerus, bilateral proximal tibia, and bilateral distal tibia. A single T.A.L.O.N. provides IO access—there are no powered tools or multiple needles necessary and no special removal tool is required. Simple step-by-step instructions and minimal insertion pressure is required to ensure that combat lifesavers and medics can use the T.A.L.O.N. effectively with proper training. Capabilities• 7-Site IO Vascular Access • Simple Delivery of life-saving fluids and medication • Rapid Resuscitation Product Attributes• Access to any IO site with one manual device• No need for additional devices, multiple needles or special removal tools• Meets CoTCCC recommendations for IO devicesClinical Benefits• First and only FDA-cleared manual IO device with 7-site access: o Sternumo Bilateral proximal humeruso Bilateral proximal tibiao Bilateral distal tibia• Delivers fluids and medications rapidly and safely

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-081

Device Description : T.A.L.O.N. 7-Site I.O. Starter SetT.A.L.O.N. IO Needle Set 1 eaEZ T.A.L.O.N. 7-Site I.O. Starter SetT.A.L.O.N. IO Needle Set 1 eaEZ-Stabilizer 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 2 eaAlcohol Prep Pad 2 eaT.A.L.O.N. IFU 1 eaEZ-Stabilizer IFU 1 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-100

Device Description : 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaIV Administration Set 1 eaNeedle Free Valve with Luer Lock 1 eaConstricting Band 1 eaIV Catheter Dressing 1 eaTransparent Film Dressing 1 ea2"x2" Gauze Pad (2 pack) 1 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : LRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-100

Device Description : 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaIV Administration Set 1 eaNeedle Free Valve with Luer Lock 1 eaConstricting Band 1 eaIV Catheter Dressing 1 eaTransparent Film Dressing 1 ea2"x2" Gauze Pad (2 pack) 1 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : LRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-100

Device Description : 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaIV Administration Set 1 eaNeedle Free Valve with Luer Lock 1 eaConstricting Band 1 eaIV Catheter Dressing 1eaTransparent Film Dressing 1 eaAdhesive Bandage 1 ea2"x2" Gauze Pad (2 pack) 1 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : LRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-100

Device Description : 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaIV Administration Set 1 eaNeedle Free Valve with Luer Lock 1 eaConstricting Band 1 eaIV Catheter Dressing 1eaTransparent Film Dressing 1 eaAdhesive Bandage 1 ea2"x2" Gauze Pad (2 pack) 1 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : LRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-110

Device Description : 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaNeedle Free Valve with Luer Lock 1 eaConstricting Band 1 eaTransparent Film Dressing 1 ea2"x2" Gauze Pad (2 pack) 1 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : LRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-110

Device Description : 18 GA. Catheter 1 ea20 GA. Catheter 1 eaSaline Flush (5c 18 GA. Catheter 1 ea20 GA. Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaNeedle Free Valve w/ Luer Lock 1 eaConstricting Band 1 eaTransparent Film Dressing 1 eaSterile Gauze Pad 2 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : No

Product Code : LRS

Prescription Use : Yes

Device Count : 1