FDA.reportPublic FDA data

Hood Speaking Valve

Primary DI
00815347023434
Brand
Hood Speaking Valve
Company
HOOD, E BENSON LABORATORIES INC
Model
LRV-4015-S
Device description
Hood Speaking Valve
Published
2016-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

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
00815347023434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815347023434008153470234348153470234340815347023434

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, single-useA sterile 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 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 to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
076603380
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815347020082Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1512-S2023-11-21
00815347020099Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1814-S2023-11-21
00815347023762Radiopaque Bronchial Stent with PostsRBSP1-1030-S2023-11-21
00815347023779Radiopaque Bronchial Stent with PostsRBSP1-1230-S2023-11-21
00815347023786Radiopaque Bronchial Stent with PostsRBSP1-1240-S2023-11-21
00815347023793Radiopaque Tracheal Stent with PostsRTSP-1450-S2023-11-21
00815347023809Radiopaque Tracheal Stent with PostsRTSP-1650-S2023-11-21
00815347023816Radiopaque Bronchial Stent with PostsRBSP1-1250-S2023-11-21
00815347024011Radiopaque Hour Glass Stent with PostsRHGS-1614-S2023-11-21
00815347024028Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1410-S2023-11-21
00815347024035Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1613-S2023-11-21
00815347020358Extra Long Tracheal T-TubeELT-06-S2015-10-27
00815347020365Long Tracheal T-TubeLT-506-S2015-10-27
00815347020372Long Tracheal T-TubeLT-507-S2015-10-27
00815347020389Extra Long Tracheal T-TubeELT-07-S2015-10-27
00815347020396Extra Long Tracheal T-TubeELT-08-S2015-10-27
00815347020402Long Tracheal T-TubeLT-508-S2015-10-27
00815347020419Extra Long Tracheal T-TubeELT-10-S2015-10-27
00815347020426Long Tracheal T-TubeLT-509-S2015-10-27
00815347020433Long Tracheal T-TubeLT-510-S2015-10-27

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