FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00848253002620
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
BE 6040
Published
2017-01-01
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
ENWCatheter, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ENWCatheter, NasopharyngealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813307013051PackageGS16In Commercial Distribution
00848253002620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307013051008133070130518133070130510813307013051
00848253002620008482530026208482530026200848253002620

GMDN Terms#

Term, Definition table
TermDefinition
Tracheoesophageal speech test catheterA non-sterile flexible tube intended to conduct exhaled air from the tracheostoma of a laryngectomized patient, via the nasal cavity, to the oesophagus as part of an oesophageal insufflation test to assess the patient’s ability to produce tracheoesophageal voice and the potential benefit of speech valve placement (via creation of a tracheoesophageal fistula). Disposable devices intended to assist catheter introduction/function (e.g., tracheostoma connector, adhesive tape) may be included. This is a single-use 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
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
00813307013174InHealth Technologies; Blom-SingerBE 20512017-01-01
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