FDA.reportPublic FDA data

LARYNGOTEC

Primary DI
04051948019377
Brand
LARYNGOTEC
Company
Andreas Fahl Medizintechnik-Vertrieb GmbH
Model
14920-1262
Device description
LARYNGOTEC KOMBI, SIZE 12/62
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTOTube, Tracheostomy (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051948019377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051948019377040519480193774051948019377

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, reusableA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes (however is not custom-made for a specific patient). It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49220329800vertrieb@fahl.de

Regulatory Flags#

DUNS number
314768383
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04051948000016SILVERVENT10000-022015-09-17
04051948000023SILVERVENT10000-032015-09-17
04051948000030SILVERVENT10000-042015-09-17
04051948000047SILVERVENT10000-052015-09-17
04051948000054SILVERVENT10000-062015-09-17
04051948000061SILVERVENT10000-072015-09-17
04051948000078SILVERVENT10000-082015-09-17
04051948000085SILVERVENT10000-092015-09-17
04051948000092SILVERVENT10000-102015-09-17
04051948000108SILVERVENT10000-112015-09-17
04051948000115SILVERVENT10000-122015-09-17
04051948000122SILVERVENT10000-132015-09-17
04051948000153SILVERVENT10002-002016-03-16
04051948000160SILVERVENT10002-012016-03-16
04051948000177SILVERVENT10002-022016-03-16
04051948000184SILVERVENT10002-032016-03-16
04051948000191SILVERVENT10002-042016-03-16
04051948000207SILVERVENT10002-052016-03-16
04051948000214SILVERVENT10002-062016-03-16
04051948000221SILVERVENT10002-072016-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035324009114TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010523TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010776TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010837TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010967TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010981TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011032TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011063TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011124TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011186TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011230TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011247TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011261TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011384TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011407TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011445TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011827TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324012619TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324012718TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013562TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013586TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013678TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013777TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013852TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013876TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013951TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014026TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014064TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014101TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014132TRACOE® comfortTracoe medical GmbHBTO2017-07-03