FDA.report

InHealth Technologies; Blom-Singer

Primary DI
00813307011613
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
BK 4100
Published
2016-09-24
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

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
00813307011613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307011613008133070116138133070116130813307011613

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.

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
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00848253002385InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
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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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