Ahold U.S.A., Inc.

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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

Tape And Bandage, Adhesive (KGX) (3) Dilator, Nasal (LWF) (2) Dressing, Wound, Drug (FRO) (2) Pad, Menstrual, Unscented (HHD) (2) Lavage, Jet (FQH) (1) Needle, Hypodermic, Single Lumen (FMI) (1)

Premarket Exempt

No Yes

Clear

CareOne - 00041520880963 Catalog Number :

Device Description : Plastic Bandages, Antibacterial, all one size, 3/4 IN x 3 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 20

CareOne - 00041520882028 Catalog Number :

Device Description : Flexible Fabric Bandages, all one size, 3/4 IN x 3 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

CareOne - 00041520882035 Catalog Number :

Device Description : Sheer Adhesive Pads Antibacterial, all one size, 3 IN x 4 IN

Device Class :

Duns Number: 170199058

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 8

Care One - 00341520005879 Catalog Number :

Device Description : 4mm 33G Pen Needle with Remover- Unifine Pentips Plus

Device Class :

Duns Number: 170199058

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Care One - 00341520310102 Catalog Number :

Device Description : Sterile Saline Wound Wash. Packaged in an aerosol (BOV) can.

Device Class : 2

Duns Number: 170199058

Premarket Exempt : No

Product Code : FRO, FQH

Prescription Use : No

Device Count : 1

CareOne - 00341520317170 Catalog Number :

Device Description : Drug free Nasal Strips, regular strength, tan large

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 30

CareOne - 00341520317354 Catalog Number :

Device Description : Drug free Nasal Strips, regular strength, clear medium

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 30

CareOne - 00341520877889 Catalog Number :

Device Description : Wound Wash, 8 FL OZ (240 mL)

Device Class : U

Duns Number: 170199058

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

Care One - 00688267021978 Catalog Number :

Device Description : MAXIPAD ULTRA THIN OVERNIGHT w/WINGS UNSCENTED

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 28

Care One - 00688267021985 Catalog Number :

Device Description : MAXIPAD ULTRA THIN LARGE SUPER w/WINGS UNSCENTED

Device Class :

Duns Number: 170199058

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 16

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