FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer; Accufit

Primary DI
00848253003504
Brand
InHealth Technologies; Blom-Singer; Accufit
Company
Freudenberg Medical, LLC
Model
BE 6084
Published
2019-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00848253003474PackageGS130In Commercial Distribution
00848253003603PackageGS16In Commercial Distribution
00848253003504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253003474008482530034748482530034740848253003474
00848253003603008482530036038482530036030848253003603
00848253003504008482530035048482530035040848253003504

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy base plate, single-useA non-sterile flexible device designed to adhere to the skin around a tracheostoma to function as an anchor for a tracheostomal device (e.g., shower shield, hands-free speech valve). It is a synthetic polymer annular disc with a slightly protruding hollow centre designed to accept the intended device; it typically includes an adhesive backing. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848253002224InHealth Technologies; Blom-SingerBE 1090EZ2026-10-06
00848253002231InHealth Technologies; Blom-SingerBE 10912026-10-06
00848253002248InHealth Technologies; Blom-SingerBE 1090EF2026-10-06
00848253002279InHealth Technologies; Blom-SingerBE 1090EZ-62026-10-06
00848253002286InHealth Technologies; Blom-SingerBE 1090EF-62026-10-06
00848253002309InHealth Technologies; Blom-SingerBE 10922026-10-06
00848253002316InHealth Technologies; Blom-SingerBE 1091-102026-10-06
00848253002323InHealth Technologies; Blom-SingerBE 1092-102026-10-06
00848253001067InHealth Technologies; Blom-SingerBE 31952016-09-24
00848253003191InHealth Technologies; Blom-SingerBE 32952018-03-01
00813307011491InHealth Technologies; Blom-SingerBE 31902016-09-24
00813307011507InHealth Technologies; Blom-SingerBE 32902016-09-24
00813307011514InHealth Technologies; Blom-SingerIN 40502016-09-24
00813307012634InHealth Technologies; Blom-SingerBE 60412018-01-01
00813307012641InHealth Technologies; Blom-SingerBE 60422018-01-01
00813307012658InHealth Technologies; Blom-SingerBE 60432018-01-01
00813307012665InHealth Technologies; Blom-SingerBE 60442018-01-01
00813307012672InHealth Technologies; Blom-SingerBE 60342018-01-01
00813307012689InHealth Technologies; Blom-SingerBE 60352018-01-01
00813307012771InHealth Technologies; Blom-SingerBE 62002017-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848253002224InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002231InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002248InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002279InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002286InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002309InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002316InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002323InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848530106430Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2026-08-15
04719874951467Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
04719874955939Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
08904428744916OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
00848530107284Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2025-08-19
14026704927453GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
14026704929723GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
00848530062316Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096922Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096946Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096953Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530103637Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096908Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530083274Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
00848530083298Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
07331791015854TrachPhone (5 pcs)Atos Medical ABBYD2023-06-19
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791002861TrachPhone (50 pcs)Atos Medical ABBYD2022-11-29
07331791009693TrachPhone (30 pcs)Atos Medical ABBYD2022-11-29