BIODERM, INC.

Address:12320 73RD COURT NORTH,LARGO,FL,33773,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

Device, Intravascular Catheter Securement (KMK) (7) Device, Paste-On For Incontinence, Non-Sterile (NOA) (2) Solvent, Adhesive Tape (KOX) (1)

Premarket Exempt

Yes

Clear

Men's Liberty - 00653599000892 Catalog Number :

Device Description : Men's Liberty, No Wipes, Brazil

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

CathGrip - 00653599000908 Catalog Number :

Device Description : CathGrip Single Strap, Small, Sterile Foil Pouch

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000915 Catalog Number :

Device Description : CathGrip Double Strap, Medium, Non-Sterile, No Wipes

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000922 Catalog Number :

Device Description : CathGrip Single Strap, Large, Non-Sterile for Medline Nutritional

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000939 Catalog Number :

Device Description : CathGrip Oval, Small, Non-Sterile for Medline Nutritional

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599001004 Catalog Number :

Device Description : Men's Liberty Patient 3 Sample Box

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

CathGrip - 00653599001066 Catalog Number :

Device Description : CathGrip Oval, Medium, Non-Sterile for Medline Nutritional

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

FreeDerm - 00653599001110 Catalog Number :

Device Description : FreeDerm Adhesive Remover Ampules, 30 per box

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

CathGrip - 00653599001127 Catalog Number :

Device Description : CathGrip Oval, Small, Non-Sterile, No Alcohol

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001134 Catalog Number :

Device Description : CathGrip Oval, Medium, Non-Sterile, No Alcohol

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

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