AccessGUDID - DEVICE: BYD CARE (00850022724183)

GUDID

Device Identifier (DI) Information

Brand Name: BYD CARE
Version or Model: FE2311
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FE2311
Company Name: Global Healthcare Product Solutions, LLC

Primary DI Number: 00850022724183
Issuing Agency: GS1
Commercial Distribution End Date: March 07, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 080884832 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61938	Surgical/examination garment kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200923	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 38 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: DO NOT use if package is damaged.

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 25.77 Square inch

Device Record Status

Public Device Record Key: c6208f5f-d2cc-4e83-8ce2-43d75d7a9adb
Public Version Date: March 15, 2021
Public Version Number: 1
DI Record Publish Date: March 07, 2021