FDA.reportPublic FDA data

TruFit™ Adhesive Housing, 30 Pack

Primary DI
00848253003931
Brand
TruFit™ Adhesive Housing, 30 Pack
Company
Freudenberg Medical, LLC
Model
BE 6088
Published
2025-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00848253003955PrimaryGS10
00848253003931Unit of UseGS10
00848253003948Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253003955008482530039558482530039550848253003955
00848253003931008482530039318482530039310848253003931
00848253003948008482530039488482530039480848253003948

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
30
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848253003634InHealth Technologies; Blom-SingerPK 21062019-07-10
00848253003641InHealth Technologies; Blom-SingerPK 21072019-07-10
00848253003399InHealth Technologies; Blom-SingerPK 21002019-06-07
00848253003405InHealth Technologies; Blom-SingerPK 21012019-06-07
00848253003412InHealth Technologies; Blom-SingerPK 21022019-06-07
00848253003429InHealth Technologies; Blom-SingerPK 21032019-06-07
00848253003436InHealth Technologies; Blom-SingerPK 21042019-06-07
00848253003443InHealth Technologies; Blom-SingerPK 21052019-06-07
00813307012597InHealth Technologies; Blom-SingerBE 60452018-01-01
00813307012603InHealth Technologies; Blom-SingerBE 60462018-01-01
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
00813307012740InHealth Technologies; Blom-SingerBE 60482016-09-24
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00848253004037StomaSoft Cleaning SwabsTSWB10TSWB102025-03-17
00848253003955TruFit™ Adhesive Housing, 6 PackBE 6088-62025-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884389976067MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
10859760005056Passy Muir PASSY-MUIR, INC.BYD2025-02-03
10810050855621ThermoFlo®TYPENEX MEDICAL LLCBYD2024-11-14
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
10850014574793HME FlexPEPPER MEDICAL INC.BYD2023-10-25
10884521082502DARCovidien LPBYD2023-09-16
10884521829060DARCovidien LPBYD2023-09-16
10884521829152DARCovidien LPBYD2023-09-16
10884521829183DARCovidien LPBYD2023-09-16
10884521829176DARCovidien LPBYD2023-09-01
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791015564Provox Life Coming Home USAAtos Medical ABBYD2022-11-29
10840330700181ProcureTwin Med, LLCBYD2022-11-02
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752105928AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141964AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141988AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752139794AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139800AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139817AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139824AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139831AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139992AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10193489139983MedlineMEDLINE INDUSTRIES, INC.BYD2022-08-04
10193489331172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BYD2022-08-04