Safeguard US Operating, LLC

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tourniquet, Nonpneumatic (GAX) (2) First Aid Kit Without Drug (OHO) (1) Gauze / Sponge,Nonresorbable For External Use (NAB) (1) Set, Blood Transfusion (BRZ) (1)

Premarket Exempt

No Yes

Clear

SWAT-T Orange Tourniquet, 100/case - M689SWATTORG010 Catalog Number : SWAT-T ORG

Device Description : SWAT-T Stretch-Wrap and Tuck TourniquetA Proven Multi-functionLife SavingFirst Aid Device

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

SWAT-T Orange Tourniquet, 100/case - M689SWATTORGCA010 Catalog Number : SWAT-T ORG-CA

Device Description : SWAT-T Stretch-Wrap and Tuck TourniquetA Proven Multi-functionLife SavingFirst Aid Device

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

TacGauze - M689TACG02020 Catalog Number : TACG02

Device Description : 1ea- 120" x4.5" sterile, rolled wrapping gauze

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

Low Titer Type O FWB Transfusion Set - M69880875020 Catalog Number : 80-875

Device Description : LOW TITER TYPE O FWB TRANSFUSION SETConstricting Band (18"x1") 1 eaSafety IV Ca LOW TITER TYPE O FWB TRANSFUSION SETConstricting Band (18"x1") 1 eaSafety IV Catheter 16gx1.25" 2 eaIV Set "Y" - Type with Filter 1 eaTransparent Film Dressing 2 eaChlorhexidine Swap 4 eaBlood Collection Bag 1 eaBeaded Cable Tie 1eaNeedle-Free Valve with Luer Lock 2 eaDD Form 572 1 eaSF518 1 ea

Device Class : 2

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : BRZ

Prescription Use : Yes

Device Count : 1

Medic Enhancement Set - M6988250403010 Catalog Number : 82-504-03

Device Description : The Medic Enhancement Set is convenience kit with a capability improvement provi The Medic Enhancement Set is convenience kit with a capability improvement providing a combination of advanced tools for the management of massive hemorrhage, airway compromise, respiratory system insults and circulatory compromise. • The set is comprised of color coded MARCH protocol devices for rapid visual identification of the appropriate tool required under the MARCH protocol.• Each set is designed to augment or enhance first respondents treatment capacities.TMT-Tourniquet 2 eaCelox Rapid 2 eaiTClamp 1 eaControl-Cric 1 eaSentinel Chest Seal 2 eaTALON IO Starter Set 1 eaBattle Bandage 2 ea

Device Class : 1

Duns Number: 118492643

Premarket Exempt : No

Product Code : OHO

Prescription Use : Yes

Device Count : 1

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