HY-VEE, 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

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (3) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (3) Tampon, Menstrual, Unscented (HEB) (2) Unit, Cryosurgical, Accessories (GEH) (1)

Premarket Exempt

Clear

HyVee Health - 00075450123777 Catalog Number :

Device Description : Hy-Vee DPS Early Result

Device Class :

Duns Number: 006925671

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

HyVee - 00075450127010 Catalog Number : 007545012701

Device Description : Wart Freezer One Step Wart Removal

Device Class : 2

Duns Number: 006925671

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

Hy-Vee Health Tampons - 00075450136081 Catalog Number :

Device Class :

Duns Number: 006925671

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 36

Hy-Vee Health Tampons - 00075450136098 Catalog Number :

Device Class :

Duns Number: 006925671

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 36

Hy-Vee Health Premium Wrist BPM - 00075450227406 Catalog Number : UB-543-HV

Device Description : Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 006925671

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Hy-Vee Health Wireless BPM - 00075450227420 Catalog Number : UA-651BLE-HV

Device Description : Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 006925671

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Hy-Vee Health Multi-User BPM - 00075450227437 Catalog Number : UA-767F-HV

Device Description : Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 006925671

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

HyVee Health - 00075450259339 Catalog Number :

Device Description : FPPL Hy-Vee DPS +/- (ER)

Device Class :

Duns Number: 006925671

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

HyVee Health - 00075450290806 Catalog Number :

Device Description : FPPL Hy-Vee SPS +/- (ER)

Device Class : 2

Duns Number: 006925671

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

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