FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00813307012153
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
BE 6405
Published
2017-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KACTube, Laryngectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813307012153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307012153008133070121538133070121530813307012153

GMDN Terms#

Term, Definition table
TermDefinition
Laryngectomy tube, sterileA sterile hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved tube, similar to a tracheostomy tube, contoured to fit the postoperative tracheal anatomy, and may have an inner cannula as part of its design. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. 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
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
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
08904428723706OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723713OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723720OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723737OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723744OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723751OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723768OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723775OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723782OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723799OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723805OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723812OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312010OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312027OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312034OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312041OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312058OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312065OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312072OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312089OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747900OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747917OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747924OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747931OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747948OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747955OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747962OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747979OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747986OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747993OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12