AccessGUDID - DEVICE: SafeSecure (16973563061812)

GUDID

Device Identifier (DI) Information

Brand Name: SafeSecure
Version or Model: EH-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd

Primary DI Number: 16973563061812
Issuing Agency: GS1
Commercial Distribution End Date: January 16, 2033
Device Count: 20
Labeler D-U-N-S® Number*: 527295522 *Terms of Use

Device Description: No description.

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):	No
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?
66197	Surgical/medical face mask, antimicrobial, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. 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 [?]
K213358	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -10 and 38 Degrees Celsius
Handling Environment Humidity: less than 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: deff7e9c-2d7d-4aa1-af50-efbad757f2fa
Public Version Date: July 28, 2022
Public Version Number: 1
DI Record Publish Date: July 20, 2022