FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EWLProsthesis, Laryngeal (Taub)

Product Code Classifications

CodeDeviceSpecialtyClass
EWLProsthesis, Laryngeal (Taub)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848253003191PrimaryGS10
00848253003207Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253003191008482530031918482530031910848253003191
00848253003207008482530032078482530032070848253003207

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep Away From Sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
800-477-5969InHealth@inhealth.com

Regulatory Flags

DUNS number
120981337
Device count
60
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 DIBrandModelCatalogPublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00848253003948TruFit™ Adhesive Housing, 30 PackBE 60882025-04-01
00848253003931TruFit™ Adhesive Housing, 6 PackBE 6088-62025-04-01
00848253004013Cleaning Brush, StandardIN 4062IN 40622025-03-25
00848253004020Cleaning Brush, LongIN 4063IN 40632025-03-25
00848253004037StomaSoft Cleaning SwabsTSWB10SPT 0022025-03-17
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolSPT 002SPT 0022025-03-14
00848253002347InHealth Technologies; Blom-SingerTP 16082023-11-03
00848253002354InHealth Technologies; Blom-Singer®TP 16102023-11-03
00848253002361InHealth Technologies; Blom-Singer®TP 16122023-11-03
00848253002378InHealth Technologies; Blom-Singer®TP 16142023-11-03
00848253002385InHealth Technologies; Blom-Singer®TP 20082023-11-03
00848253002408InHealth Technologies; Blom-Singer®TP 20102023-11-03
00848253002606InHealth Technologies; Blom-Singer®TP 20122023-11-03
00848253003092InHealth Technologies; Blom-Singer®TP 20142023-11-03
00848253003115InHealth Technologies; Blom-Singer®TP 2208-LEF2023-11-03
00848253003122InHealth Technologies; Blom-Singer®TP 2210-LEF2023-11-03
00848253003139InHealth Technologies; Blom-Singer®TP 2212-LEF2023-11-03
00850004312001EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-100PN1007960-1002021-06-15
00848253003665InHealth TechnologiesVP 2206-LEF2021-02-03

Other Devices Sharing Product Codes

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
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00848253003672InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003689InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003696InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
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00848253003405InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003429InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253003443InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
00848253001487InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00848253001500InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
07331791010743Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010750Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010767Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010774Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010781Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010798Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010804Provox® Vega™Atos Medical ABEWL2017-06-12
07331791010811Provox® Vega™Atos Medical ABEWL2017-06-12