| Primary Device ID | 00622554055017 |
| NIH Device Record Key | 4cce8307-6f1f-422f-96b9-f5ed62702816 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | I-MED Surgical Mask |
| Version Model Number | 5100 |
| Catalog Number | 5100 |
| Company DUNS | 249008772 |
| Company Name | I-Med Pharma Inc |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com | |
| Phone | +1(514)758-9998 |
| ilan@imedpharma.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00622554051002 [Primary] |
| GS1 | 00622554055017 [Unit of Use] |
| QKR | Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-10-05 |
| Device Publish Date | 2020-06-18 |
| 00622554050012 - I-MED Nitrile Powder-Free and Latex-Free Gloves | 2022-10-05 The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft while providing excellent chemical resist |
| 00622554055017 - I-MED Surgical Mask | 2022-10-05Mask 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 |
| 00622554055017 - I-MED Surgical Mask | 2022-10-05 Mask intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from tra |
| 00622554052016 - I-MED KN95 Respirator Mask | 2022-10-05 Mini-fiber, high electrostatic filter, filtration efficiency of dust & powder above 95%. Continually repels contamination of blo |
| 00622554051019 - I-MED Protective Isolation Gown | 2022-10-05 The I-MED Protective Isolation Gowns provide anti-bacterial protection with a comfortable fit. The I-MED Protective Isolation Go |
| 00622554008907 - I-RELIEF Hot and Cold Therapy Eye Mask | 2021-09-20 Hot & Cold Therapy Eye Mask with ThermaBeadsTM for the relief of symptoms associated with Blepharitis, Dry Eye Disease, Meibomia |
| 00622554057004 - I-MED Non-Contact Infrared digital Clinical Thermometer | 2020-12-04 Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F |
| 00622554054010 - I-MED Protective Facshield | 2020-07-15 The I-MED Protective Faceshield is a one-time-use face protection shield. It protects against splatter and airborne particles wi |