FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00813307013112
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
BE 6096
Published
2017-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCGDilator, Tracheal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCGDilator, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813307013112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307013112008133070131128133070131120813307013112

GMDN Terms#

Term, Definition table
TermDefinition
Tracheoesophageal device introducerA hand-held manual instrument designed to assist in the non-surgical placement of a tracheoesophageal device (e.g., speech valve, speech valve occluder, fistula gauge/dilator). It is a synthetic polymer holder onto which the tracheoesophageal device is distally mounted and directed to the target site through the tracheostoma. It is intended to be used by the patient at home (for non-indwelling devices) and clinician in the healthcare facility (for indwelling devices). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04054462917778evonosevonos GmbH & Co. KGKCG2026-08-14
04054462917785evonosevonos GmbH & Co. KGKCG2026-08-14
00190776399351MillenniumAvalign Technologies, Inc.KCG2025-05-30
04049047041818GimmiGimmi GmbHKCG2025-05-08
04049047700043GimmiGimmi GmbHKCG2025-05-08
G043280420BEARBear-Ent, LLCKCG2024-08-03
00840183513764BR Surgical, LLCBR Surgical, LLCKCG2024-06-10
00888515246850BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
00888515246867BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
00888515246881BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
G586E98477130Novo SurgicalNOVO SURGICAL, INC.KCG2023-12-18
G25010005140Laborde Dilator ForcepN S SURGICAL COMPANYKCG2023-04-29
00842331179754Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-14
00842331160448Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-13
00842331139123Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-11
00842331136054Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-10
00887482049303Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482049310Symmetry LabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482124123Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482124130Symmetry LabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482002322Symmetry DelabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-09-07
00887482002605Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-09-07
00190776184469MillenniumAvalign Technologies, Inc.KCG2021-11-01
00190776184476MillenniumAvalign Technologies, Inc.KCG2021-11-01
04035324017263TRACOE experc Dilation SetTracoe medical GmbHKCG2021-03-05
04046826135782MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
04046826135799MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
04046826135805MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
10649111117039SklarSKLAR CORPORATIONKCG2019-03-13
10649111134012SklarSKLAR CORPORATIONKCG2019-03-13