Safeguard US Operating, LLC

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

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Filters

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

Bedding, Disposable, Medical (KME) (3) Pack, Hot Or Cold, Disposable (IMD) (3) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (3) Airway, Nasopharyngeal (BTQ) (2) Dressing, Compression (MHW) (2)

Premarket Exempt

No Yes

Clear

Battle Wrap - M68902001040 Catalog Number : 02-001

Device Description : 1ea. - 6' x 4", clear, self-adhering, compression wrap

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : MHW

Prescription Use : No

Device Count : 1

Battle Wrap - M68902001050 Catalog Number : 02-001

Device Description : 1ea. - 6' x 4", clear, self-adhering, compression wrap

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : MHW

Prescription Use : No

Device Count : 1

Hypothermia Prevention Blanket - M689041050 Catalog Number : 04-105

Device Description : HYPOTHERMIA PREVENTION BLANKET1 ea - 7.5' x 6.5' Blizzard Light Blanket

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : KME, IMD

Prescription Use : No

Device Count : 1

Hypothermia Prevention Blanket - M68904105010 Catalog Number : 04-105

Device Description : HYPOTHERMIA PREVENTION BLANKET1 ea - 7.5' x 6.5' Blizzard Light Blanket

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : IMD, KME

Prescription Use : No

Device Count : 1

Hypothermia Prevention Blanket - M68904105020 Catalog Number : 04-105

Device Description : HYPOTHERMIA PREVENTION BLANKET1 ea - 7.5' x 6.5' Blizzard Light Blanket

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : IMD, KME

Prescription Use : No

Device Count : 1

Eye Shield - M68906200020 Catalog Number : 06-200

Device Description : 1ea - 2.5" x 3.25", aluminum eye shield w/garter

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

Eye Shield - M68906205040 Catalog Number : 06-205

Device Description : 1ea - 2.375" x 3", polycarbonate eye shield w/garter

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

Eye Shield - M68906205050 Catalog Number : 06-205

Device Description : 1ea - 2.375" x 3", polycarbonate eye shield w/garter3ea - 0.875" x 2.625" adhesive strips

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

Nasal Trumpet - M68911110030 Catalog Number : 11-110

Device Description : 1ea - Robertazzi 28Fr Nasopharyngeal Airway, 1ea - Lubricating Jelly

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : BTQ

Prescription Use : No

Device Count : 1

Nasal Trumpet - M68911112020 Catalog Number : 11-112

Device Description : 1ea - Sterile, 28 Fr Nasopharyngeal Airway, 1ea - Surgical Lubricant

Device Class : 1

Duns Number: 118492643

Premarket Exempt : Yes

Product Code : BTQ

Prescription Use : No

Device Count : 1

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