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

Needle, Aspiration And Injection, Disposable (GAA) (3) Airway, Nasopharyngeal (BTQ) (2) Dressing, Wound, Occlusive (NAD) (2) First Aid Kit Without Drug (OHO) (1) Needle, Catheter (GCB) (1) Set, Tubing And Support, Ventilator (W Harness) (BZO) (1)

Premarket Exempt

No Yes

Clear

Nasal Trumpet - M68911128020 Catalog Number : 11-128

Device Description : 1ea - sterile, pre-lubricated nasopharyngeal airway

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : BTQ

Prescription Use : No

Device Count : 1

Nasal Trumpet - M68911128030 Catalog Number : 11-128

Device Description : 1ea - sterile, pre-lubricated nasopharyngeal airway

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : BTQ

Prescription Use : No

Device Count : 1

Sentinel Chest Seal - M68920001030 Catalog Number : 20-001

Device Description : 1 ea - dual vent chest seal with Sentinel 10x adhesive; 1 ea - wipe

Device Class : 1

Duns Number: 118492643

Premarket Exempt : No

Product Code : NAD

Prescription Use : Yes

Device Count : 1

Sentinel Chest Seal - M68920001040 Catalog Number : 20-001

Device Description : 1 ea - sterile dual vent chest seal with Sentinel 10x adhesive; 1 ea - wipe

Device Class : 1

Duns Number: 118492643

Premarket Exempt : No

Product Code : NAD

Prescription Use : Yes

Device Count : 1

Sentinel Chest Trauma Kit - M68920510030 Catalog Number : 20-510

Device Description : SENTINEL CHEST TRAUMA KIT2 ea Sentinel Dual vent Chest seals with Sentinel 10x e SENTINEL CHEST TRAUMA KIT2 ea Sentinel Dual vent Chest seals with Sentinel 10x extreme strength adhesive1 ea Dart sterile 14 gauge x 3.25" needle / catheter for chest decompression1 ea Dart Target 1 ea wipe

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Sentinel Chest Trauma Kit - M68920510050 Catalog Number : 20-510

Device Description : SENTINEL CHEST TRAUMA KIT2 ea - Sentinel Dual vent Chest seals with Sentinel 10x SENTINEL CHEST TRAUMA KIT2 ea - Sentinel Dual vent Chest seals with Sentinel 10x extreme strength adhesive1 ea - Dart sterile, 14 gauge x 3.25", needle / catheter for chest decompression1 ea - Dart Target 1 ea - wipe

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Dart - M68921001010 Catalog Number : 21-001

Device Description : 14GA 3.25" Needle with Catheter for Chest Decompression

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : GCB

Prescription Use : Yes

Device Count : 1

Dart Target Chest Decompression Set - M68921011020 Catalog Number : 21-011

Device Description : 1ea-placement template; 1ea sterile, 14 gauge x 3.25", needle/catheter for chest 1ea-placement template; 1ea sterile, 14 gauge x 3.25", needle/catheter for chest decompression

Device Class : 1

Duns Number: 118492643

Premarket Exempt : No

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Mojo Crisis Responder - Advanced - M6892156801010 Catalog Number : 81-568-01

Device Description : Mojo Medical Bags are equipped withMARCH Medical Gear in our simplified, color-c Mojo Medical Bags are equipped withMARCH Medical Gear in our simplified, color-coded treatment system linkingicon identifiers to a treatment categorywithin the MARCH protocol.MASSIVE HEMORRHAGEAIRWAYRESPIRATIONCIRCULATIONHEAD & HYPOTHERMIA

Device Class : 1

Duns Number: 118492643

Premarket Exempt : No

Product Code : OHO

Prescription Use : Yes

Device Count : 1

SAVe1 Conversion Kit - M6892511050020 Catalog Number : 25-110-50

Device Description : Automedx Conversion Kit

Device Class : 1

Duns Number: 118492643

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

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