Face Mask with shield tie on

GUDID 16973479070014

SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO.,LTD.

Surgical/medical face mask, single-use
Primary Device ID16973479070014
NIH Device Record Keyfbeea1c4-0954-4b8e-b57b-decb6309ba85
Commercial Distribution StatusIn Commercial Distribution
Brand NameFace Mask with shield tie on
Version Model NumberNM-MA-008
Company DUNS421090090
Company NameSHANGHAI NEO-MEDICAL IMPORT & EXPORT CO.,LTD.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106973479070017 [Primary]
GS116973479070014 [Unit of Use]

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-02
Device Publish Date2020-06-24

Devices Manufactured by SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO.,LTD.

16973479070014 - Face Mask with shield tie on2020-07-02
16973479070014 - Face Mask with shield tie on2020-07-02
16973479070021 - Face Mask earloop2020-07-02
16973479070038 - Face Mask tie on2020-07-02
16973479070045 - Face Mask with shield earloop2020-07-02

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