FDA.reportPublic FDA data

BYD CARE

Primary DI
00850022724176
Brand
BYD CARE
Company
BYD Precision Manufacture Co., Ltd.
Model
FE2311
Catalog number
FE2311
Device description
BYD CARESingle-use Face MaskNon-sterileSoft & Easy to BreathBFE >= 98%PFE >= 98%Flammability: Class IASTM Level 3Flat MaskSpecifications:175mm×95mm / 6.89in.×3.74in10pcs/bag ×5bags
Published
2020-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200923000Single-use Surgical MaskByd Precision Manufacturer Co., Ltd.2020-08-26FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022724176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022724176008500227241768500227241760850022724176

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area25.77Square inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00DO NOT use if package is damaged.
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius38 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)2932886byd.care@byd.com

Regulatory Flags#

DUNS number
545255648
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022724169BYD CAREFE2311FE23112020-09-06
00860003645154BYD CAREDF1122DF11222020-04-06
00860003624807BYD CAREFF1311FF13112020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G539MM3S1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3S2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
00050428143315CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
00050428340561CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
10304040195472EssentialsHENRY SCHEIN, INC.FXX2026-09-04
10304040195489EssentialsHENRY SCHEIN, INC.FXX2026-09-04
00810194402623AiraAIRA, LLCFXX2026-08-26
20197344219237MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-31
06974960061330S&JXiantao S&J Protective Products Co., LtdFXX2026-07-29
00840456202814JMUJMU DENTAL, INCFXX2026-07-24
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30