BYD CARE FE2311

GUDID 00850022724169

BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level 3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags

BYD Precision Manufacture Co., Ltd.

Surgical/examination garment kit
Primary Device ID00850022724169
NIH Device Record Key619c0176-6c92-4dbc-a6ab-e013dc74d55e
Commercial Distribution Discontinuation2050-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameBYD CARE
Version Model NumberFE2311
Catalog NumberFE2311
Company DUNS545255648
Company NameBYD Precision Manufacture Co., Ltd.
Device Count1
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com
Phone1(800)2932886
Emailbyd.care@byd.com

Device Dimensions

Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch
Area/Surface Area25.77 Square inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.
Storage Environment TemperatureBetween -20 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT use if package is damaged.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850022724169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-09-14
Device Publish Date2020-09-06

On-Brand Devices [BYD CARE]

00860003624807Single-use Face Mask Soft & Easy to Breath Use as Surgical Mask
00860003645154N95 Health Care Particulate Respirator and Surgical Mask
00850022724169BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammabili
00850022724176BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammabili

Trademark Results [BYD CARE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BYD CARE
BYD CARE
88981204 not registered Live/Pending
BYD Company Ltd.
2020-03-19
BYD CARE
BYD CARE
88840620 not registered Live/Pending
BYD Company Ltd.
2020-03-19

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