FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00848253003191
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
BE 3295
Published
2018-03-01
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
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
00848253003191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253003191008482530031918482530031910848253003191

GMDN Terms#

Term, Definition table
TermDefinition
Tracheoesophageal device insertion capsuleA non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
1
DM exempt
false
Premarket exempt
false
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
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
00813307012788InHealth Technologies; Blom-SingerBE 62102017-01-01

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