FDA.reportPublic FDA data

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
OTC
true

Product Codes#

Code, Name table
CodeName
CATCANNULA, NASAL, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50822383138126PrimaryGS10
00822383138121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238313812650822383138126
00822383138121008223831381218223831381210822383138121

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
867673159
Device count
50
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118600361Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118607988Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118609616Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118614900Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617338Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617352Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617376Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617390Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617413Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617437Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617895Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620901Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620918Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620925Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620932Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118621052Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
04719874951023Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-21
04719874952471Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-21
04719874950682Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950699Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950705Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950712Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950729Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950736Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874951306Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874951313Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952419Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952426Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952433Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952464Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20