FDA.reportPublic FDA data

InHealth Technologies

Primary DI
00848253001395
Brand
InHealth Technologies
Company
Freudenberg Medical, LLC
Model
PK 2001F-R2
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTOTube, Tracheostomy (W/Wo Connector)
BTRTube, Tracheal (W/Wo Connector)
BYDCondenser, Heat And Moisture (Artificial Nose)
JOHTube Tracheostomy And Tube Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848253001395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253001395008482530013958482530013950848253001395

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
Kit
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
10887709197395BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197401BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197418BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197425BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197432BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197449BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197456BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197463BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197470BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197487BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197494BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197500BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197517BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197524BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197531BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197548BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197555BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197562BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197579BivonaICU MEDICAL, INC.JOH2026-07-06
15019517382860ICU Medical, Inc.ICU MEDICAL, INC.BTO2026-07-06
00348783010640Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010657Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010664Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010671Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010695Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010701Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010718Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010725Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010732Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010749Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09