DEVICE: Defend (00840326416556)

Device Identifier (DI) Information

Defend
MK-7300C
In Commercial Distribution
MK-7300C
Young Innovations, Inc.
00840326416556
GS1

1
004193103 *Terms of Use
Defend Level 3 Facemask-blue 50/bx
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
66199 Surgical/medical face mask, non-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 does not include an antimicrobial/antiviral agent(s) 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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FXX Mask, surgical
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K202903 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b8697fa3-ca4c-4405-9738-d5fa44830f59
August 19, 2024
1
August 09, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10840326416553 50 00840326416556 In Commercial Distribution Box
20840326416550 10 10840326416553 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1 (800) 275-0020
customerservice@defend.com
CLOSE