I-Med Pharma Inc

Address:7190 Fredrick Banting Rd.,St Laurent Quebec,CA

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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

Decontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles (QLB) (3) Decontamination systems for facemasks, surgical masks, face shields, and safety glasses (QLA) (3) Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance (QKR) (2) Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) (HOY) (2) Thermometer, electronic, clinical (FLL) (1) Gown, examination (FME) (1) Pack, hot or cold, reusable (IME) (1) THERMOMETER, CLINICAL COLOR CHANGE (FQZ) (1)

Premarket Exempt

Yes

Clear

I-RELIEF Hot and Cold Therapy Eye Mask - 00622554008907 Catalog Number : 0890

Device Description : Hot & Cold Therapy Eye Mask with ThermaBeadsTM for therelief of symptoms associa Hot & Cold Therapy Eye Mask with ThermaBeadsTM for therelief of symptoms associated with Blepharitis, Dry Eye Disease, MeibomianGland Disease (MGD), Styes and Chalazia as well as headaches, sinuspressure, tension, swelling and puffiness.

Device Class : 1

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

I-MED Nitrile Powder-Free and Latex-Free Gloves - 00622554050005 Catalog Number : 5000

Device Description : The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibl The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft while providing excellent chemical resistance as well as high virus protection. Enhanced tactile sensitivity allows for accurate work with smaller items.

Device Class :

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : QLA, QLB

Prescription Use : No

Device Count : 100

I-MED Surgical Mask - 00622554051002 Catalog Number : 5100

Device Description : Mask intended to be worn by personnel during medical procedures to protect both Mask intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer

Device Class :

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : QKR

Prescription Use : No

Device Count : 50

I-MED KN95 Respirator Mask - 00622554052009 Catalog Number : 5200

Device Description : Mini-fiber, high electrostatic filter, filtration efficiency of dust & powder ab Mini-fiber, high electrostatic filter, filtration efficiency of dust & powder above 95%. Continually repels contamination of blood and saliva. Inner cover sweat absorbant with water resistant outer cover. Low breathing resistance and high filtration efficiency.

Device Class :

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : QLB, QLA, QKR

Prescription Use : No

Device Count : 20

I-MED Single Use Face Mask - 00622554053006 Catalog Number : 5300

Device Description : Single-use face shield is intended to be worn by personnel during medical proced Single-use face shield is intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer

Device Class : 1

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : HOY, QLA, QLB

Prescription Use : No

Device Count : 110

I-MED Protective Facshield - 00622554054003 Catalog Number : 5400

Device Description : The I-MED Protective Faceshield is a one-time-use face protection shield. It pro The I-MED Protective Faceshield is a one-time-use face protection shield. It protects against splatter and airborne particles with a wrap-around face shield that is suitable for procedures demanding an increased level of protection.

Device Class : 1

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 110

I-MED Protective Isolation Gown - 00622554055000 Catalog Number : 5500

Device Description : The I-MED Protective Isolation Gowns provide anti-bacterial protection with a co The I-MED Protective Isolation Gowns provide anti-bacterial protection with a comfortable fit. The I-MED Protective Isolation Gowns are manufactured from a premium impervious SMS material base fabric and are available in white and sizes S to 2XL. 100% waterproof efficiency and high-repellency medical-grade protection Ties at back of neck and waist, with elastic wrist or knitted cuff.

Device Class : 1

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 25

I-MED Non-Contact Infrared digital Clinical Thermometer - 00622554057004 Catalog Number : 5700

Device Description : Ideal for quickly detecting elevated body temperature using a non-contact design Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F (32.0°C to 42.5°C) without contact. Accurate to 0.5°F (0.3°C) with 0.1°F/°C resolution. Adjustable alarm alerts user visually and audibly when temperature exceeds programmed limit. Optimum measurement distance of 2 in. to 5.9-in. (5 to 15 cm).

Device Class : 1

Duns Number: 249008772

Premarket Exempt : Yes

Product Code : FQZ, FLL

Prescription Use : No

Device Count : 1

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