FDA.reportPublic FDA data

Mask tracheostomy O2Star M/L

Primary DI
04048675382461
Brand
Mask tracheostomy O2Star M/L
Company
Drägerwerk AG & Co. KGaA
Model
MP01924
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
04048675382461PrimaryGS10
04048675420590Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675382461040486753824614048675382461
04048675420590040486754205904048675420590

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+494518820info@draeger.com

Regulatory Flags#

DUNS number
315578914
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675594956Atlan A100 XL86212002026-08-03
04048675594963Atlan A10086211002026-08-03
04048675822363Babyroo TN300MU303002026-07-15
04048675795124Sample Line 2,5m68738502026-07-21
04048675824121Seattle PAPMP022542026-06-11
04048675001065OxyTrace IncuMX010502015-10-24
04048675016403Savina System84144502015-10-24
04048675017097Babytherm 8010 System2M223802015-10-24
04048675017165Caleo2M500002015-10-24
04048675041382Babytherm 8004 System2M223702015-10-24
04048675042174NBP Cuff L+, 31-40/55cm, Box10MP009322022-06-22
04048675251422Savina 30084178002015-10-24
04048675686712VentStar Resus heated (N)MP170302025-05-14
04048675686736VentStar AutoBreath heated (N)MP170312025-05-14
04048675641308Babyleo TN5002M611002026-03-23
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

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
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