ARCHIVED 3. List of Medical Devices for Exceptional Importation and Sale [2020-04-21]

Notice to reader:

This is an archived list. Please refer to the most current version of this list.

Medical devices included on this list are called "designated medical devices" and are eligible for the exceptional importation and sale provisions provided for in the Interim Order.

Supersedes: 2020-04-11
Date issued: 2020-04-17

Access archived versions of this list.

List of Medical Devices for Exceptional Importation and Sale

Medical Device Medical Device Category Country of Manufacture Name of Manufacturer MDEL/MDL number Date
Non-Woven Face Masks I China Shenzhen Delong Huale Electronic Co. Ltd MDEL 2332 2020-04-10
Non-Woven Face Masks I China Xiantao Xingrong Protective Products Co., Ltd. MDEL 2332 2020-04-10
Face Mask for Single Use I China Wuxi Yushou Medical Appliances Co., Ltd. MDEL 11700 2020-04-10
N95 Respirators I China Suzhou Fangtian Industries Co., Ltd. MDEL 11700 2020-04-11
N95 Respirators I China Makrite Industries Inc. MDEL 11700 2020-04-11
Medical Grade Face Masks I China V&Q Manufacturing Corporation MDEL 9174 2020-04-17
Isolation Gowns I China Wuhan Orient Honest International Trade Co., Ltd MDEL11707 2020-04-17
Face Mask 3-Ply with Ear Loop / Tie I China Shandong Zhushi Pharmaceutical Group Co., Ltd. MDEL 6151 2020-04-17
Surgical Masks I China Xiantao Xingrong Protective Products Co., Ltd. MDEL 6732 2020-04-17
Face Masks I China Halemann Technology Co., Ltd MDEL 11765 2020-04-17
3-Ply Face Masks, with Earloops I China Hubei Fullcare Protective Products Co., Ltd. MDEL 1841 2020-04-17
Newport HT-50 Ventilator III USA Newport Medical Instruments Inc. MDEL 11862 2020-04-17
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