PUBLIX SUPER MARKETS, 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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (4) Floss, Dental (JES) (3) Accessories, Soft Lens Products (LPN) (1) Lubricant, Personal (NUC) (1) Needle, Hypodermic, Single Lumen (FMI) (1)

Premarket Exempt

Yes No

Clear

Publix - Dual Memory BPM - 00041415054783 Catalog Number : UA-774P

Device Description : Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 006922009

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

PUBLIX Personal Lubricant - 00041415055759 Catalog Number :

Device Description : 4oz (113 g) Personal Lubricating Jelly

Device Class : 2

Duns Number: 006922009

Premarket Exempt : No

Product Code : NUC

Prescription Use : No

Device Count : 1

Publix - Pen Needles with Remover 5mmx31g Mini - 00041415068780 Catalog Number : AN 3850PX

Device Description : For use with injectors for the subcutaneous injection of approved drugs, including insulin

Device Class :

Duns Number: 006922009

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Publix Comfort Formula Multi-purpose Disinfecting Solution - 00041415069763 Catalog Number : Not Applicable

Device Description : Multi-purpose Solution for Contact Lenses

Device Class : 2

Duns Number: 006922009

Premarket Exempt : No

Product Code : LPN

Prescription Use : No

Device Count : 1

Publix - BPM - 00041415076785 Catalog Number : UA-611P

Device Description : Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 006922009

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Publix - Deluxe BPM - 00041415078789 Catalog Number : UA-651BLE-P

Device Description : Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 006922009

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Publix - 00041415079724 Catalog Number :

Device Description : FLSP SIDE MNT HT 90

Device Class : 1

Duns Number: 006922009

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Publix - Wrist BPM - 00041415079786 Catalog Number : UB-521P

Device Description : Digital Wrist Blood Pressure Monitor

Device Class : 2

Duns Number: 006922009

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Publix - 00041415080720 Catalog Number :

Device Description : FLSS 40M INTSE CLN ICY MNT CD

Device Class : 1

Duns Number: 006922009

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Publix - 00041415090729 Catalog Number :

Device Description : FLSS 40M EX COMF MNT CD

Device Class : 1

Duns Number: 006922009

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

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