RespoKare

Primary DI
00840039200565
Brand
RespoKare
Company
INNONIX TECHNOLOGIES LIMITED
Model
RK-200-2001A-605C
Device description
RespoKare Anti-viral Mask
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OUKSurgical Mask With Antimicrobial/Antiviral Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUKSurgical Mask With Antimicrobial/Antiviral AgentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101128000BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013Filligent Limited2011-05-26OUK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840039200626PrimaryGS10
00840039200565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840039200626008400392006268400392006260840039200626
00840039200565008400392005658400392005650840039200565

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 typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
680118887
Device count
5
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840039200015RespoKare11102021-01-13
00840039200626RespoKareRK-200-2001A-605C2021-02-25
00840039200640RespoKareRK-200-2005A-610C2021-08-10
00840039200558RespoKareRK-200-2001A-624C2021-01-22
00840039200213RespoKare11032021-01-13
00840039200527RespoKare11102021-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40852212003717ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-08-05
50852212003714ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-08-05
10852212003716ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-01-13
30852212003710ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-01-13
00852212003719ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2024-10-21
80852212003715ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2024-10-21
00840039200640RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-08-10
00888277359867CuradMEDLINE INDUSTRIES, INC.OUK2021-04-15
40888277359865CuradMEDLINE INDUSTRIES, INC.OUK2021-04-15
00860006561826Cufitec Surgical MaskNBC MESHTEC INC.OUK2021-03-31
00888277359850MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OUK2021-03-16
00840039200626RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-02-25
00840039200558RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-22
00840039200015RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-13
00840039200527RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-13
00840039200213RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-13
00708820228818Meijer MEIJER, INC.OUK2018-12-28
10884389129814MedlineMEDLINE INDUSTRIES, INC.OUK2016-10-14
10884389148020MedlineMEDLINE INDUSTRIES, INC.OUK2016-10-14
30884389129818MedlineMEDLINE INDUSTRIES, INC.OUK2016-10-14