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

CONTAINER, SPECIMEN, NON-STERILE (NNI) (2) Disinfectant, medical devices (LRJ) (1) Latex patient examination glove (LYY) (1) Lubricant, patient (KMJ) (1) Mask, surgical (FXX) (1) Non-surgical isolation gown (OEA) (1) Oximeter (DQA) (1) SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE (DXN) (1) Thermometer, electronic, clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

Hopkins Medical Products® - 00817643022456 Catalog Number : 698725

Device Description : Chemo Spillt Kit

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022463 Catalog Number : 699100

Device Description : CaviWipes Bleach 10.5 inch x 6 inch, 90 Wipes/Canister

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022470 Catalog Number : 699559

Device Description : Individual 6 inchx10 inch Bio Bag

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022487 Catalog Number : 699569

Device Description : Individual 10 inchx10 inch Bio Bag

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022494 Catalog Number : 728340

Device Description : Lubricating Jelly 3gm Each

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022500 Catalog Number : 695260

Device Description : MRSA Plus Kit Small Adult

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022517 Catalog Number : 690052

Device Description : Blood Pressure Cuff Barrier Sleeve

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Hopkins Medical Products Handheld Pulse Oximeter - 00817643023071 Catalog Number : 594810

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Hopkins Medical Products® - 10817643020145 Catalog Number : 19696

Device Description : Procedure Mask PK50

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 10817643020312 Catalog Number : 525875BX

Device Description : Thermometer Probe Covers 20/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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