FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00813307011767
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
BE 8026H
Published
2017-01-01
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
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813307011767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307011767008133070117678133070117670813307011767

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube speech valveA device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
1
DM exempt
false
Premarket exempt
true
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
08904428798421OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428798292OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
44710810101913N/AGALEMED CORPORATIONBYD2026-03-04
04710810101939N/AGALEMED CORPORATIONBYD2026-03-04
00810050855815ThermoFlo®TYPENEX MEDICAL LLCBYD2026-01-26
07331791181153Provox Life Oxygen (10 pcs)Atos Medical ABBYD2025-12-16
07331791181160Provox Life Oxygen (30 pcs)Atos Medical ABBYD2025-12-16
10848530107281Heat Moisture ExchangerSUNSET HEALTHCARE SOLUTIONS, INC.BYD2025-08-19
34026704928935GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928942GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928959GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928966GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928973GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928980GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704927457GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927467GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927740GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929010GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929024GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929031GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929492GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929522GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929536GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929720GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929864GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929041GIBECKTELEFLEX INCORPORATEDBYD2025-07-30
20884389976064MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
00848253003948TruFit™ Adhesive Housing, 30 PackFreudenberg Medical, LLCBYD2025-04-01
00848253003931TruFit™ Adhesive Housing, 6 PackFreudenberg Medical, LLCBYD2025-04-01