Device
Safety Face Shield Visor Protective Mask w/Headstrap Universal size 200/cs
Manufacturer
Twin Med, LLC
Twin Med, LLC
Model: PCFS200
Catalog: PCFS200
DI: 10840330704882
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Safety Face Shield Visor Protective Mask w/Headstrap Universal size 200/cs
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
124eaf94-55dc-425f-86fc-4616c754a5bc
Distribution Status:
In Commercial Distribution
DUNS Number:
107071289
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
30840330704886
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
200
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840330704882
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840330704882
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 11961
Name: Face splash shield, single-use
Definition:
A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.
FDA Product Codes
LYU
Accessory, Surgical Apparel