KROGER CO., THE

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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) (4) Syringe, Piston (FMF) (3) Floss, Dental (JES) (1) Gauze / Sponge,Nonresorbable For External Use (NAB) (1) Dressing, Wound, Hydrophilic (NAC) (1) Tape And Bandage, Adhesive (KGX) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

Kroger Pen Needles - 00011110338235 Catalog Number :

Device Description : Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Kroger - 00011110350756 Catalog Number : 112-621-000

Device Description : KROGER DIGITAL PROBE COVERS ORAL

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Kroger - 00011110351210 Catalog Number :

Device Description : Waterproof Adhesive Tape, 1/2 IN x 5 YDS

Device Class : 1

Duns Number: 006999528

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Kroger - 00011110351227 Catalog Number :

Device Description : Non-Stick Pads, all one size, 2 IN x 3 IN

Device Class :

Duns Number: 006999528

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 10

Kroger - 00011110351241 Catalog Number :

Device Description : Rolled Gauze, 2 IN x 2.5 YDS

Device Class : 1

Duns Number: 006999528

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

Kroger Insulin Syringes - 00011110353221 Catalog Number :

Device Description : 1cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : No

Device Count : 100

Kroger Insulin Syringes - 00011110353238 Catalog Number :

Device Description : .5cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMF, FMI

Prescription Use : No

Device Count : 100

Kroger Insulin Syringes - 00011110353245 Catalog Number :

Device Description : .3cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : No

Device Count : 100

Kroger Tampons - 00011110353597 Catalog Number :

Device Description : Multi pack of 40 - 8 light/16 Regular/16 Super

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Kroger - 00011110353863 Catalog Number :

Device Description : FLOSS TAPE WAX

Device Class : 1

Duns Number: 006999528

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

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