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) (4) Container, sharps (MMK) (2) Thermometer, electronic, clinical (FLL) (2) GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE (GDY) (1) Ventilator, emergency, manual (resuscitator) (BTM) (1)

Premarket Exempt

No Yes

Clear

Hopkins Medical Products® - 00817643020353 Catalog Number : 552105

Device Description : Hopkins Res Q Mask Replaceable Valves 10/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : BTM

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020360 Catalog Number : 576005

Device Description : Thermoscan Pro6000 Disposable Probe Covers 200/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : FLL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020377 Catalog Number : 578610

Device Description : Thermoscan Pro4000 Disposable Probe Covers 200/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : FLL

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020384 Catalog Number : 599590-BK

Device Description : Onyx Vantage Pulse Ox- Black

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Hopkins Medical Products® - 00817643020391 Catalog Number : 599590-PL

Device Description : Onyx Vantage 9590 Pulse Ox- Purple

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Hopkins Medical Products® - 00817643020407 Catalog Number : 599590-RD

Device Description : Onyx Vantage 9590 Pulse Ox- Red

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Hopkins Medical Products® - 00817643020414 Catalog Number : 599590-RL

Device Description : Onyx Vantage 9590 Pulse Ox- Royal Blue

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Hopkins Medical Products® - 00817643020421 Catalog Number : 610388

Device Description : Emergency OB/Precipitous Birth Kit

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020438 Catalog Number : 660150

Device Description : Leak Tight 1.5 Qt Sharps Container

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : MMK

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643020445 Catalog Number : 660200

Device Description : Leak Tight 2 Qt Sharps Container

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : MMK

Prescription Use : No

Device Count : 1

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