BYD CARE FE2311
GUDID 00850022724190
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
Global Healthcare Product Solutions, LLC
Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit| Primary Device ID | 00850022724190 |
| NIH Device Record Key | 6f556ca1-8c1b-462e-b40d-14338723d877 |
| Commercial Distribution Discontinuation | 2021-03-07 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BYD CARE |
| Version Model Number | FE2311 |
| Catalog Number | FE2311 |
| Company DUNS | 080884832 |
| Company Name | Global Healthcare Product Solutions, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com | |
| Phone | 1(800)2932886 |
| byd.care@byd.com |
Device Dimensions
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
| Area/Surface Area | 25.77 Square inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Storage Environment Temperature | Between -20 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850022724190 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200923
FDA Product Code
| FXX | Mask, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-15 |
| Device Publish Date | 2021-03-07 |
On-Brand Devices [BYD CARE]
| 00850022724190 | BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammabili |
| 00850022724183 | BYD 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 88981204 not registered Live/Pending |
BYD Company Ltd. 2020-03-19 |
 BYD CARE 88840620 not registered Live/Pending |
BYD Company Ltd. 2020-03-19 |
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