FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383161709
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
MASK 007P
Device description
RespiratoryRespiratory Disposables Product Description: PediTracheotomy Mask 50/CS
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00822383161709PackageGS150In Commercial Distribution
50822383161704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383161709008223831617098223831617090822383161709
5082238316170450822383161704

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822383012155Silver Sport 16" ReclBackSSP16RBDDAV2026-02-03
00822383012162Silver Sport 16" Full ArmSSP16RBDFAV2026-02-03
00822383012179Silver Sport 18" Det DeskSSP18RBDDAV2026-02-03
00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
00822383034683Silver Sport HD 22"SSP22RBDDAV2026-02-03
00822383034690Silver Sport 24" HDSSP24RBDDAV2026-02-03
00822383030135AeroFly Wheelchair, 18”, Black, SFAF18FDABK-SF2025-11-18
00822383030142AeroFly Wheelchair, 18”, Gray, SFAF18FDAGY-SF2025-11-18
00822383033204AeroFly Wheelchair 20:, Black, SFAF20FDABK-SF2025-11-11
00822383033211AeroFly Wheelchair 20:, Gray, SFAF20FDAGY-SF2025-11-11
00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
00822383033235AeroFly transport Chair, 18", GrayAFT18GY-SF2025-11-11
00822383030333DriveCFPC17FS2025-09-03
00822383000190Drive35BWBE-FM-SC0535BWBE-FM-SC052025-09-02
00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
00822383000213Drive35MCBE-A-SC0535MCBE-A-SC052025-09-02
00822383000220Drive35MCBE-FM-SC0535MCBE-FM-SC052025-09-02
00822383000237Drive42BWBE-B-SC0542BWBE-B-SC052025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344155122MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
20885632467384HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467391HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467445HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467452HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
15694311111894Nox Nasal Pressure Cannula with FilterNox Medical ehf.CAT2026-01-28
00850077887017AERIS Airway - MSA Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887048AERIS Airway - Male Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887079AERIS Airway - Female Luer KitAirway Innovations, Inc.CAT2026-01-08
20889483223014Montgomery DMESUNMED, LLCCAT2025-12-30
20197344162694CARINGMEDLINE INDUSTRIES, INC.CAT2025-11-27
20197344158406HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158413HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158420HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158437HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158444HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158451HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULTIntersurgical IncorporatedCAT2025-09-23
20197344158468HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161161MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161178MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161185MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161192MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161208MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161215MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161222MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161239MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344155061MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21