CUTTING EDGE HC BRANDS LLC

Address:314 N ALTA VISTA BLVD,Los Angeles,CA,90036,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

Tubing, Noninvasive (GAZ) (8) Mask, Oxygen (BYG) (2)

Premarket Exempt

Yes No

Clear

O2-Life™ - 00850108006714 Catalog Number : RTG-06002

Device Description : O2-Life Oxygen Tubing 14' (4.3m) Crush Resistant Standard Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

O2-Life™ - 00850108006721 Catalog Number : RTG-06004

Device Description : O2-Life Oxygen Tubing 21' (6.4m) Crush Resistant Standard Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

O2-Life™ - 00850108006745 Catalog Number : RTG-06001

Device Description : 02-Life Oxygen Tubing 7' (2.1m) Crush Resistant Universal Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

O2-Life™ - 00850108006752 Catalog Number : RTG-06003

Device Description : O2-Life Oxygen Tubing 14' (4.3m) Crush Resistant Standard Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

O2-Life™ - 00850108006769 Catalog Number : RTG-06005

Device Description : O2-Life Oxygen Tubing 25' (7.62m) Crush Resistant Standard Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

O2-Life™ - 00850108006776 Catalog Number : RTG-06006

Device Description : O2-Life Oxygen Tubing 30' (9.14m) Crush Resistant Standard Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

O2-Life™ - 00850108006783 Catalog Number : RTG-06007

Device Description : O2-Life Oxygen Tubing 40' (12.19m) Crush Resistant Standard Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

O2-Life™ - 00850108006790 Catalog Number : RTG-06008

Device Description : O2-Life Oxygen Tubing 50' (15.24m) Crush Resistant Standard Connector

Device Class : 2

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Trach O-Life - 00850108006882 Catalog Number : RTG-04016

Device Description : Adult Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The trach Adult Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostomy mask is used to administer aerosol or oxygen into tracheostomy of a surgical patient. It is intended for channeling gases for the purpose of administration of oxygen to patient. It is used to connect to an active medical device.

Device Class : 1

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Trach O-Life - 00850108006899 Catalog Number : RTG-04017

Device Description : Pediatric Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The t Pediatric Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostomy mask is used to administer aerosol or oxygen into tracheostomy of a surgical patient. It is intended for channeling gases for the purpose of administration of oxygen to patient. It is used to connect to an active medical device.

Device Class : 1

Duns Number: 080216804

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

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