FDA.report

Adult Tracheostomy Mask with 22mm Swivel Connector and Head Strap

Primary DI
05055788756286
Brand
Adult Tracheostomy Mask with 22mm Swivel Connector and Head Strap
Company
FLEXICARE MEDICAL LIMITED
Model
032-10-091U
Published
2020-01-28
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

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055788756286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788756286050557887562865055788756286

GMDN Terms

TermDefinition
Tracheostomy mask, oxygenA device designed to deliver oxygen or a mixture of oxygen and air to a patient who has a tracheostomy airway. It is connected to an oxygen/medical air source with tubing and is constructed of plastic. The device can be used over a tracheal tube or stoma. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
504406273
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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