Respiratory Kit

Primary DI
00848530080792
Brand
Respiratory Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
AISIOO1CM005L
Catalog number
AISIOO1CM005L
Device description
This kit contains: 1 CM005L Deluxe Full Face CPAP Mask - Large, 1 TUB06 Durable CPAP Tubing - 6ft, 1 RES019 Oxygen Enrichment Adapter, 1 RES3015 Oxygen Supply. Tube - 15ft.
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530080792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530080792008485300807928485300807920848530080792

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, reusableA flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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