Skip to content

Regard™ N95SRGRESP-REG

by Resource Optimization & Innovation, L.L.C.

Regard™ N95SRGRESP-REG is a Class II device made by Resource Optimization & Innovation, L.L.C., listed in FDA GUDID since 18 Mar 2026 (UDI-DI 10326053123457), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10326053123457 UDI-DI Date18 Mar 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Regard™
Generic name
Surgical/medical respirator, non-antimicrobial, single-use
Model / reference
N95SRGRESP-REG
Primary DI / UDI-DI
10326053123457
FDA product code
MSH
GMDN term
Surgical/medical respirator, non-antimicrobial, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MSH (Respirator, Surgical).

Other devices from Resource Optimization & Innovation, L.L.C.

See all devices from Resource Optimization & Innovation, L.L.C. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)