Coloplast A/S

Address:HOLTEDAM 1,HUMLEBAEK Hovedstaden,DK

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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

Bandage, liquid, skin protectant (NEC) (5) COLLECTOR, OSTOMY (EXB) (3) BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE (NNW) (1) Irrigator, ostomy (EXD) (1)

Premarket Exempt

No Yes

Clear

Coloplast - 00762123001097 Catalog Number : 2320

Device Description : Coloplast Rings. Pre-cut 20 mm

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 30

Coloplast - 00762123001103 Catalog Number : 2325

Device Description : Coloplast Rings. Pre-cut 25 mm

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 30

Coloplast - 00762123001110 Catalog Number : 2330

Device Description : Coloplast Rings. Pre-cut 30 mm

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 30

Coloplast - 00762123001127 Catalog Number : 2340

Device Description : Coloplast Rings. Pre-cut 40 mm

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 30

Coloplast - 00762123001134 Catalog Number : 2350

Device Description : Coloplast Rings. Pre-cut 50 mm

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 30

Assura - 00762123023433 Catalog Number : 12830

Device Description : Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Set.

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EXD

Prescription Use : Yes

Device Count : 1

Conveen Security+ - 00762123030196 Catalog Number : 21346

Device Description : Conveen Security+. Urine collection bag. Bedside drainage bag. Inlet tube: 55 i Conveen Security+. Urine collection bag. Bedside drainage bag. Inlet tube: 55 inch (140 cm). Two step outlet. incl. 1 x bag hanger. Volume 68 oz (2000 ml).

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : NNW

Prescription Use : No

Device Count : 30

Assura - 00762123033609 Catalog Number : 12110

Device Description : Alterna Protective Seal / Assura Protective Seal / Alterna ostomy pouch / Ass Alterna Protective Seal / Assura Protective Seal / Alterna ostomy pouch / Assura Ostomy pouch. 1-Piece closed, with filter. Opaque. Mini. Mini. Base Plate Precut Start Hole Size 20 mm, Base Plate Max Cut Size 65 mm, Base Plate Type Flat.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 30

Assura - 00762123033630 Catalog Number : 12130

Device Description : Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy pouch / Ass Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy pouch / Assura Ostomy pouch. 1-piece closed. Transparent. Midi. Midi. Base Plate Precut Start Hole Size 20 mm, Base Plate Max Cut Size 65 mm, Base Plate Type Flat.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 30

Assura - 00762123033647 Catalog Number : 12140

Device Description : Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy Pouch / Ass Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy Pouch / Assura Ostomy pouch. 1-piece closed. Opaque. Midi. Midi. Base Plate Precut Start Hole Size 20 mm, Base Plate Max Cut Size 65 mm, Base Plate Type Flat.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 30

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