HOPKINS UNIFORM COMPANY

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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

Oximeter (DQA) (3) SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE (DXN) (3) Thermometer, electronic, clinical (FLL) (3) Speculum, vaginal, nonmetal (HIB) (1)

Premarket Exempt

No Yes

Clear

Hopkins Medical Products® - 00817643020599 Catalog Number : 545901

Device Description : Welch Allyn Disposable Sheaths For KSI

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : HIB

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020605 Catalog Number : 579221

Device Description : Suretemp Thermometer Disposable Probe Covers

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020612 Catalog Number : 21811

Device Description : Wound Care Management Kit

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020629 Catalog Number : 21813

Device Description : Wound Care Management Kit With Carry Tote

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020636 Catalog Number : 43310

Device Description : Premier Vital Signs Kit

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020643 Catalog Number : 43311

Device Description : Hopkins® Select Vital Signs Kit

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020650 Catalog Number : 520921

Device Description : Sprague Deluxe Combo Kit With Thermometer and Oximeter

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020667 Catalog Number : 524818

Device Description : Eco Vital Signs Kit

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020674 Catalog Number : 525268

Device Description : Child Vital Signs Combo Kit

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020681 Catalog Number : 525269

Device Description : Adult Vital Signs Combo Kit

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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