FDA.report

Tracheostomy Oxygen Maskc

Primary DI
00848530089955
Brand
Tracheostomy Oxygen Maskc
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES2230
Device description
Pediatric Tracheostomy Mask
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BYFMask, Oxygen, Low Concentration, Venturi

Product Code Classifications

CodeDeviceSpecialtyClass
BYFMask, Oxygen, Low Concentration, VenturiAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530089955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530089955008485300899558485300899550848530089955

GMDN Terms

TermDefinition
Aerosol face mask, rebreathing, single-useA flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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