FDA.reportPublic FDA data

TRACHEOTEC

Primary DI
04051948029949
Brand
TRACHEOTEC
Company
Andreas Fahl Medizintechnik-Vertrieb GmbH
Model
18920-06
Device description
TRACHEOTEC VARIO CUFF, SIZE 6
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051948029949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051948029949040519480299494051948029949

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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24026704941081SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941095SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941101SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941118SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
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34026704941132SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
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44026704617195TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617201TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617211TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617235TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617911HUDSON RCITELEFLEX INCORPORATEDBTR2025-11-20
34026704930976SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930983SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930990SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
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24026704931037SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931041SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931058SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931065SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30