Freudenberg Medical, LLC

Address:2301 Centennial Blvd,Jeffersonville,IN,47130,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tube, Laryngectomy (KAC) (10) Condenser, Heat And Moisture (Artificial Nose) (BYD) (1) Device, Fixation, Tracheal Tube (CBH) (1) Prosthesis, Laryngeal (Taub) (EWL) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003306 Catalog Number :

Device Description : Laryngectomy Tube, 12/55mm, non-sterile, non-fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003313 Catalog Number :

Device Description : Laryngectomy Tube, 12/55mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003320 Catalog Number :

Device Description : Laryngectomy Tube, 12/36mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003337 Catalog Number :

Device Description : Laryngectomy Tube, 10/55mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003344 Catalog Number :

Device Description : Laryngectomy Tube, 10/36mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003351 Catalog Number :

Device Description : Laryngectomy Tube, 9/55mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003368 Catalog Number :

Device Description : Laryngectomy Tube, 9/36mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003375 Catalog Number :

Device Description : Laryngectomy Tube, 8/55mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer; StomaSoft - 00848253003382 Catalog Number :

Device Description : Laryngectomy Tube, 8/36mm, non-sterile, fenestrated

Device Class : 1

Duns Number: 120981337

Premarket Exempt : Yes

Product Code : KAC

Prescription Use : Yes

Device Count : 1

InHealth Technologies; Blom-Singer - 00848253003399 Catalog Number :

Device Description : Post-Operative Care Kit with 9/55 Tube & ClassicFlow HME

Device Class : 1

Duns Number: 120981337

Premarket Exempt : No

Product Code : KGX, CBH, BYD, KAC, EWL

Prescription Use : Yes

Device Count : 1

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