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

Needle, Hypodermic, Single Lumen (FMI) (7) Syringe, Piston (FMF) (7) Lancet, Blood (FMK) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Pip - 00732671109422 Catalog Number : 942-2

Device Description : Control Solution - L2 (High)

Device Class : 1

Duns Number: 016069284

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

NovaPlus - 10732671100419 Catalog Number : 10041

Device Description : Pressure Activated Safety Heel-Stick Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 1

NovaPlus - 10732671100518 Catalog Number : 10051

Device Description : Pressure Activated Safety Heel-Stick Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 1

LiteTouch - 10732671105100 Catalog Number :

Device Description : MediCore's "Litetouch" Insulin Syringe

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 10

LiteTouch - 10732671105117 Catalog Number :

Device Description : MediCore's "Litetouch" Insulin Syringe

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 10

LiteTouch - 10732671105124 Catalog Number :

Device Description : MediCore's "LiteTouch" Insulin Syringe

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMF, FMI

Prescription Use : Yes

Device Count : 10

LiteTouch - 10732671105131 Catalog Number :

Device Description : MediCore's "LiteTouch Insulin Syringe

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMF, FMI

Prescription Use : Yes

Device Count : 10

LiteTouch - 10732671105148 Catalog Number :

Device Description : MediCore's "LiteTouch" Insulin Syringe

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMF, FMI

Prescription Use : Yes

Device Count : 10

LiteTouch - 10732671105155 Catalog Number :

Device Description : MediCore's "LiteTouch" Insulin Syringe

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMF, FMI

Prescription Use : Yes

Device Count : 10

LiteTouch - 10732671105162 Catalog Number :

Device Description : MediCore's "LiteTouch" Insulin Syringe

Device Class :

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMF, FMI

Prescription Use : Yes

Device Count : 10

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