FDA.report

DRIVE

Primary DI
50822383138126
Brand
DRIVE
Company
Drive Devilbiss Healthcare
Model
MASK 007A
Device description
Respiratory Respiratory Disposables Product Description Adult Tracheotomy Mask 50/case
Published
2020-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CATCANNULA, NASAL, OXYGEN

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50822383138126PrimaryGS10
00822383138121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238313812650822383138126
00822383138121008223831381218223831381210822383138121

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

Regulatory Flags

DUNS number
867673159
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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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