Model: 2084-04-PR
Catalog: 2084-04-PR
DI: 00850078013026
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
CAPR PR HELMET
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c498f045-43de-485e-861f-7e0938679c0a
Distribution Status:
In Commercial Distribution
DUNS Number:
078715452
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10850078013023
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850078013026
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850078013026
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 35102
Name: Surgical helmet system
Definition:
A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.
FDA Product Codes
FXZ
Helmet, Surgical
Premarket Submissions
Submission Number:
K040485
Supplement Number:
000