ABENA NORTH AMERICA, INC.

Address:4551 Glencoe Ste 100,Marina del Rey,CA,90292,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

Garment, Protective, For Incontinence (EYQ) (10)

Premarket Exempt

No Yes

Clear

Abena - 05713571000540 Catalog Number :

Device Description : Abena San Premium holds 27 fluid ounces/800 ml, for individuals for width and le Abena San Premium holds 27 fluid ounces/800 ml, for individuals for width and length measurements of 17x8".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000564 Catalog Number :

Device Description : Abena San Premium holds 38 fluid ounces/1200 ml, for individuals for width and l Abena San Premium holds 38 fluid ounces/1200 ml, for individuals for width and length measurements of 21 x 11".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000588 Catalog Number :

Device Description : Abena San Premium holds 54 fluid ounces/1600 ml, for individuals for width and l Abena San Premium holds 54 fluid ounces/1600 ml, for individuals for width and length measurements of 25x12".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000601 Catalog Number :

Device Description : Abena San Premium holds 71 fluid ounces/2100 ml, for individuals for width and l Abena San Premium holds 71 fluid ounces/2100 ml, for individuals for width and length measurements of 25x14".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000625 Catalog Number :

Device Description : Abena San Premium holds 85 fluid ounces/2500 ml, for individuals for width and l Abena San Premium holds 85 fluid ounces/2500 ml, for individuals for width and length measurements of 25x14".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000649 Catalog Number :

Device Description : Abena San Premium holds 81 fluid ounces/2400 ml, for individuals for width and l Abena San Premium holds 81 fluid ounces/2400 ml, for individuals for width and length measurements of 29x15".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000663 Catalog Number :

Device Description : Abena San Premium holds 95 fluid ounces/2800 ml, for individuals for width and l Abena San Premium holds 95 fluid ounces/2800 ml, for individuals for width and length measurements of 29x15".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000687 Catalog Number :

Device Description : Abena San Premium holds 115 fluid ounces/3400 ml, for individuals for width and Abena San Premium holds 115 fluid ounces/3400 ml, for individuals for width and length measurements of 29x15".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000700 Catalog Number :

Device Description : Abena San Premium holds 68 fluid ounces/2000 ml, for individuals for width and l Abena San Premium holds 68 fluid ounces/2000 ml, for individuals for width and length measurements of 29x15".

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Abena - 05713571000724 Catalog Number :

Device Class : 1

Duns Number: 078740398

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

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