FDA.report

Vital Signs™

Primary DI
30889483569423
Brand
Vital Signs™
Company
Sunmed Group Holdings, LLC
Model
001226
Catalog number
001226
Device description
Pediatric Tracheostomy Mask
Published
2025-02-25
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
BYGMask, Oxygen
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483569423PackageGS150In Commercial Distribution
10190752142060PreviousGS10
10889483569429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948356942330889483569423
1019075214206010190752142060
1088948356942910889483569429

GMDN Terms

TermDefinition
Tracheostomy mask, aerosolA device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
119058668
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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30889483570665AirLife™0018230018232025-03-27
30889483570672AirLife™0018240018242025-03-27
30889483570689AirLife™0018300018302025-03-27
30889483570863AirLife™0019510019512025-03-27
30889483570887AirLife™0019550019552025-03-27
30889483571679AirLife™0037600037602025-03-27
30889483571686AirLife™0037620037622025-03-27
30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
30889483572126AirLife™0P17760P17762025-03-27
30889483572164AirLife™0Y37700Y37702025-03-27

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