FDA.report

DURAVENT

Primary DI
04051948006643
Brand
DURAVENT
Company
Andreas Fahl Medizintechnik-Vertrieb GmbH
Model
11200-06
Device description
DURAVENT XL, SIZE 6
Published
2016-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications

CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04051948006643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04051948006643040519480066434051948006643

GMDN Terms

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

Contacts

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 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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