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Rsdl F5408ENG

by Emergent Protective Products USA Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817129020013 UDI-DIDate2 Dec 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

1 recall · FDA

    • Terminated Z-0773-2023 FDA Class I initiated 24 Nov 2022

    Complaints of leaking packets were received.

Specification

GUDID

Trade Name
Rsdl
Generic Name
Hazardous chemical decontamination agent, professional
Model / Reference
F5408ENG
Primary DI / UDI-DI
00817129020013
510(k) Number
FDA Product Code
MAC
GMDN Term
Hazardous chemical decontamination agent, professional
Device Class
Class I
Regulation Number
878.4014
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hazardous chemical decontamination agent, professional

Cleared under the same submission (K023969)

Similar devices

Also classified as Hazardous chemical decontamination agent, professional.

Other devices from Emergent Protective Products USA Inc.

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No