FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00813307013174
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
BE 2051
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
false

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
00813307013174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307013174008133070131748133070131740813307013174

GMDN Terms#

Term, Definition table
TermDefinition
Tracheoesophageal fistula gaugeA non-sterile, hand-held, manual non-surgical instrument intended to be transiently inserted into a tracheoesophageal fistula (puncture) for measuring its length to determine appropriate tracheoesophageal speech valve size prior to placement; it may also be intended to temporarily dilate the fistula to facilitate insertion of the speech valve. It a synthetic polymer cylindrical shaft with graduated markings, attached to a handle, designed to be manually inserted via the tracheostoma by a clinician; devices intended to assist insertion may be included. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
1
DM exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813307011552InHealth Technologies; Blom-SingerBE 60502017-01-01
00813307011569InHealth Technologies; Blom-SingerBE 20502017-01-01
00813307013099InHealth Technologies; Blom-SingerBE 60362017-01-01
00813307013105InHealth Technologies; Blom-SingerBE 20362017-01-01
00813307013181InHealth Technologies; Blom-SingerBE 20522017-01-01
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00850004312001EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-100PN1007960-1002021-06-15
00850004312049Steerable Introducer Sheath 12FSS120065PN1008533-0042020-01-13
00850004312018Steerable Introducer Sheath 8.5F Small CurlSS085075SPN1008533-0012019-10-25
00850004312025Steerable Introducer Sheath 8.5F Medium CurlSS085075MPN1008533-0022019-10-25
00850004312032Steerable Introducer Sheath 8.5F Large CurlSS085075LPN1008533-0032019-10-25
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

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