AMITY HOLDINGS, LLC

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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

Lancet, Blood (FMK) (5) Needle, Hypodermic, Single Lumen (FMI) (4) Instrument, Surgical, Disposable (KDC) (1)

Premarket Exempt

No Yes

Clear

NovaPlus - 00732671002310 Catalog Number : 20031

Device Description : Micro-Preemie Button Activated Safety Heel-Stick Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 1

NovaPlus - 00732671002419 Catalog Number : 20041

Device Description : Preemie Button Activated Safety Heel-Stick Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 1

NovaPlus - 00732671002518 Catalog Number : 20051

Device Description : Newborn Button Activated Safety Heel-Stick Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 1

RediCap - 00732671005816 Catalog Number : 581

Device Description : Tamper Evident Syringe Cap

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Lite Touch - 00732671006004 Catalog Number : 600

Device Description : LiteTouch Safety Needle

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

LiteTouch - 00732671006011 Catalog Number : 601

Device Description : Safety Needle

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

LiteTouch - 00732671006028 Catalog Number : 602

Device Description : Safety Needle

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

LiteTouch - 00732671006035 Catalog Number : 603

Device Description : Safety Needle

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

ReadyLance - 00732671008015 Catalog Number : 801

Device Description : Safety Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 100

ReadyLance - 00732671008022 Catalog Number : 802

Device Description : Safety Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

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