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) (8) Solvent, Adhesive Tape (KOX) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

Yes

Clear

CathGrip - 00653599000595 Catalog Number :

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

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000625 Catalog Number :

Device Description : CathGrip PegProtect, Sterile

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

FreeDerm - 00653599000649 Catalog Number :

Device Description : FreeDerm Adhesive Remover 6 ml Wipe

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

CathGrip - 00653599000656 Catalog Number :

Device Description : CathGrip Double Strap, Medium, No Alcohol, Sterile

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000663 Catalog Number :

Device Description : CathGrip Single Strap, Large, No Alcohol, Sterile

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

BioPlus+ - 00653599000670 Catalog Number :

Device Description : BioPlus+ Wipe

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

CathGrip - 00653599000687 Catalog Number :

Device Description : CathGrip Oval, Medium, Sterile

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000694 Catalog Number :

Device Description : CathGrip Oval, Medium, Non-Sterile

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000717 Catalog Number :

Device Description : CathGrip Oval, Small, Sterile

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599000724 Catalog Number :

Device Description : CathGrip Oval, Small, Non-Sterile

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

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