FDA.reportPublic FDA data

SpectraShield™ Defender™ 9500

Primary DI
00860004147381
Brand
SpectraShield™ Defender™ 9500
Company
NEXERA MEDICAL, LLC
Model
N95 Comfort Shape - 50 each
Catalog number
NDA9500-50
Device description
Antimicrobial N95 - 8 Hour Extended Use
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONTN95 Respirator With Antimicrobial/Antiviral Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONTN95 Respirator With Antimicrobial/Antiviral AgentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090414000
K120244000
K150729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090414000SPECTRASHIELD 9500 SURGICAL MASKNexera Medical, Inc.2011-02-24ONT
K120244000SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORNexera Medical, Inc.2012-07-05ONT
K150729000SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc.2015-12-29ONT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004147381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004147381008600041473818600041473810860004147381

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, antimicrobialA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is designed to create an airtight seal against the user’s face and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(954) 824-0700info@NexeraMed.com

Regulatory Flags#

DUNS number
128835277
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004147305SpectraShield™ Guardian™ 9500N95 Flat Fold - 02 eachNGA9500-022026-10-14
00860004147312SpectraShield™ Guardian™ 9500N95 Flat Fold - 50 eachNGA9500-502026-10-14
00860004147329SpectraShield™ Guardian™ 9500N95 Flat Fold - 24 eachNGA9500-242026-10-14
00860004147336SpectraShield™ Guardian™ 9900N99 Flat Fold - 02 eachNGA9900-022026-10-14
00860004147343SpectraShield™ Guardian™ 9900N99 Flat Fold - 24 eachNGA9900-242026-10-14
00860004147350SpectraShield™ Guardian™ 9900N99 Flat Fold - 50 eachNGA9900-502026-10-14
00860004147367SpectraShield™ Defender™ 9500N95 Comfort Shape - 02 eachNDA9500-022026-10-14
00860004147374SpectraShield™ Defender™ 9500N95 Comfort Shape - 24 eachNDA9500-242026-10-14
00860004147398SpectraShield™ Defender™ 9900N99 Comfort Shape - 02 eachNDA9900-022026-10-14
00860016228702SpectraShield™ Defender™ 9900N99 Comfort Shape - 24 eachNDA9900-242026-10-14
00860016228719SpectraShield™ Defender™ 9900N99 Comfort Shape - 50 eachNDA9900-502026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860004147305SpectraShield™ Guardian™ 9500NEXERA MEDICAL, LLCONT2026-10-14
00860004147312SpectraShield™ Guardian™ 9500NEXERA MEDICAL, LLCONT2026-10-14
00860004147329SpectraShield™ Guardian™ 9500NEXERA MEDICAL, LLCONT2026-10-14
00860004147336SpectraShield™ Guardian™ 9900NEXERA MEDICAL, LLCONT2026-10-14
00860004147343SpectraShield™ Guardian™ 9900NEXERA MEDICAL, LLCONT2026-10-14
00860004147350SpectraShield™ Guardian™ 9900NEXERA MEDICAL, LLCONT2026-10-14
00860004147367SpectraShield™ Defender™ 9500NEXERA MEDICAL, LLCONT2026-10-14
00860004147374SpectraShield™ Defender™ 9500NEXERA MEDICAL, LLCONT2026-10-14
00860004147398SpectraShield™ Defender™ 9900NEXERA MEDICAL, LLCONT2026-10-14
00860016228702SpectraShield™ Defender™ 9900NEXERA MEDICAL, LLCONT2026-10-14
00860016228719SpectraShield™ Defender™ 9900NEXERA MEDICAL, LLCONT2026-10-14