FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00813307014393
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
IN 2004-LETO
Published
2018-01-01
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
EWLProsthesis, Laryngeal (Taub)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWLProsthesis, Laryngeal (Taub)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813307014393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307014393008133070143938133070143930813307014393

GMDN Terms#

Term, Definition table
TermDefinition
Tracheoesophageal fistula spacer/occluderA non-sterile device intended to be placed in a surgically-created tracheoesophageal fistula/puncture (usually for more than 30 days) to: 1) maintain its shape and patency following total laryngectomy; and 2) to prevent leakage of fluids from the oesophagus into the trachea. It is made of synthetic polymer and includes a double retention flange and a neck fastening strap; it is not intended to enable voice production. It is inserted through the tracheostoma and replaced by a clinician as needed (indwelling type); devices to assist placement may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep Away From Sunlight

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
00848253002347InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2023-11-03
00848253002354InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002361InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002378InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002385InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002408InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253002606InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003092InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003115InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003122InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
00848253003139InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
07331791015175Provox Life FreeHands FlexiVoice Set PlusAtos Medical ABEWL2022-12-07
00848253003665InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003672InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003689InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003696InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003634InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-07-10
00848253003641InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-07-10
00848253003399InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003405InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003412InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003429InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003436InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003443InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253001470InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00848253001494InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00848253001517InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00813307010647InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01
00813307010661InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01
00813307010685InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01