FDA.report

NeoMaskL

Primary DI
04048675250005
Brand
NeoMaskL
Company
Drägerwerk AG & Co. KGaA
Model
8418619
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675250005PrimaryGS10
04048675429029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675250005040486752500054048675250005
04048675429029040486754290294048675429029

GMDN Terms

TermDefinition
CPAP nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+494518820info@draeger.com

Regulatory Flags

DUNS number
315578914
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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04048675034735Adapter 9/16" to 6mmMP004162026-02-04
04048675013532CORRUGATED BELLOWS K84100792015-10-24
04048675558736Filter SafeStar 55 PlusMP057902023-01-09
04048675665762Filter SafeStar 90 PlusMP057852023-01-09
04048675665786Filter SafeStar 60A PlusMP057952023-01-09
04048675665823Filter/HME TwinStar HEPA PlusMP058012023-01-09
04048675253426Mask NovaStarTS,NIV,w/SE,LMP015812015-10-24
04048675253402Mask NovaStarTS,NIV,w/SE,SMP015792015-10-24
04048675253419Mask NovaStarTS,NIV,w/SE,MMP015802015-10-24
04048675379300IBP Cable Utah26064912026-01-07
04048675557722IBP Adapter Cable Dräger 7pin26075582026-01-07
04048675379072IBP cable Becton Dickinson26064882026-01-06
04048675379089IBP Cable Abbott, Medex26064902026-01-06
04048675379096IBP cable Edwards26064892026-01-06
04048675557739IBP Adapter Cable Drager 10pin26075592026-01-06
04048675428909ThermoTrace_Peripheral_5pcsMX110012015-10-24
04048675428916ThermoTrace Core (5pcs)MX110002015-10-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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