FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00813307011514
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
IN 4050
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00813307011514PrimaryGS10
00848253002651Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307011514008133070115148133070115140813307011514
00848253002651008482530026518482530026510848253002651

GMDN Terms#

Term, Definition table
TermDefinition
Tracheoesophageal speech valve irrigation deviceA non-sterile hand-held device intended to be used for the in situ washing of an indwelling tracheoesophageal speech valve by water irrigation to remove organic matter (e.g., phlegm). It is in the form of a water-fillable squeeze bulb with a distal nozzle that is inserted through the tracheostoma into the central lumen of the valve; it is intended to be used routinely by a patient in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-477-5969InHealth@inhealth.com

Regulatory Flags#

DUNS number
120981337
Device count
3
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
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00848253003948TruFit™ Adhesive Housing, 30 PackBE 60882025-04-01
00848253003931TruFit™ Adhesive Housing, 6 PackBE 6088-62025-04-01
00848253004013Cleaning Brush, StandardIN 4062IN 40622025-03-25
00848253004020Cleaning Brush, LongIN 4063IN 40632025-03-25
00848253004037StomaSoft Cleaning SwabsTSWB10SPT 0022025-03-17
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolSPT 002SPT 0022025-03-14
00848253002347InHealth Technologies; Blom-SingerTP 16082023-11-03
00848253002354InHealth Technologies; Blom-Singer®TP 16102023-11-03
00848253002361InHealth Technologies; Blom-Singer®TP 16122023-11-03
00848253002378InHealth Technologies; Blom-Singer®TP 16142023-11-03
00848253002385InHealth Technologies; Blom-Singer®TP 20082023-11-03
00848253002408InHealth Technologies; Blom-Singer®TP 20102023-11-03
00848253002606InHealth Technologies; Blom-Singer®TP 20122023-11-03
00848253003092InHealth Technologies; Blom-Singer®TP 20142023-11-03
00848253003115InHealth Technologies; Blom-Singer®TP 2208-LEF2023-11-03
00848253003122InHealth Technologies; Blom-Singer®TP 2210-LEF2023-11-03
00848253003139InHealth Technologies; Blom-Singer®TP 2212-LEF2023-11-03
00850004312001EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-100PN1007960-1002021-06-15
00848253003665InHealth TechnologiesVP 2206-LEF2021-02-03

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
00848253003405InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003429InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003443InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003191InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2018-03-01
00848253001487InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00848253001500InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
07331791010743Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010750Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010767Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010774Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010781Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010798Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010804Provox® Vega™Atos Medical ABEWL2017-06-12