FDA.report

InHealth Technologies; Blom-Singer; Advantage

Primary DI
00813307010784
Brand
InHealth Technologies; Blom-Singer; Advantage
Company
Freudenberg Medical, LLC
Model
AS 2012-NS
Published
2018-01-01
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

Related Records

Contact Domains

Product Codes

CodeName
EPEBrush, Cleaning, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
EPEBrush, Cleaning, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813307010784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307010784008133070107848133070107840813307010784

GMDN Terms

TermDefinition
Tracheoesophageal device introducerA non-sterile, 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight; Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
800-477-5969inhealth@inhealth.com

Regulatory Flags

DUNS number
120981337
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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00848253004013Cleaning Brush, StandardFreudenberg Medical, LLCEPE2025-03-25
00848253004020Cleaning Brush, LongFreudenberg Medical, LLCEPE2025-03-25
00348783005110Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
00348783005127Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
10630094174041Bioseal Inc.BIOSEALEPE2023-09-18
10630094174096Bioseal Inc.BIOSEALEPE2023-09-18
07331791016493Provox TubeBrush 8 mmAtos Medical ABEPE2022-11-25
07331791016509Provox TubeBrush 12 mmAtos Medical ABEPE2022-11-25
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30649111028575SklarSKLAR CORPORATIONEPE2019-07-17
30649111029107SklarSKLAR CORPORATIONEPE2019-07-17
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24026704265163KMEDICTELEFLEX INCORPORATEDEPE2018-09-15