FDA.reportPublic FDA data

Panje Voice Button

Primary DI
00815347023465
Brand
Panje Voice Button
Company
HOOD, E BENSON LABORATORIES INC
Model
PVP-12
Device description
Panje Voice Prosthesis
Published
2016-05-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EWLProsthesis, Laryngeal (Taub)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWLProsthesis, Laryngeal (Taub)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815347023465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815347023465008153470234658153470234650815347023465

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848253002347InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2023-11-03
00848253002354InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002361InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002378InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002385InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002408InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002606InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003092InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003115InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003122InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003139InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
07331791015175Provox Life FreeHands FlexiVoice Set PlusAtos Medical ABEWL2022-12-07
00848253003665InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003672InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003689InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003696InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003634InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-07-10
00848253003641InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-07-10
00848253003399InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003405InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003412InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003429InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003436InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003443InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253001470InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00848253001494InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00848253001517InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00813307010647InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01
00813307010661InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01
00813307010685InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01