RespoKare

Primary DI
00840039200640
Brand
RespoKare
Company
INNONIX TECHNOLOGIES LIMITED
Model
RK-200-2005A-610C
Device description
The RespoKare Anti-viral Child Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The RespoKare Anti-viral Child Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6% and zinc 1.6%) that inactivate influenza viruses.
Published
2021-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192105000Innonix Antiviral Child's Face MaskInnonix Technologies Limited2019-11-29OUK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840039200640PrimaryGS10
00840039200817Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840039200640008400392006408400392006400840039200640
00840039200817008400392008178400392008170840039200817

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
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840039200015RespoKare11102021-01-13
00840039200626RespoKareRK-200-2001A-605C2021-02-25
00840039200558RespoKareRK-200-2001A-624C2021-01-22
00840039200213RespoKare11032021-01-13
00840039200565RespoKareRK-200-2001A-605C2021-02-25
00840039200527RespoKare11102021-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479280919McKessonMCKESSON MEDICAL-SURGICAL INC.OXZ2026-02-26
40612479280920McKessonMCKESSON MEDICAL-SURGICAL INC.OXZ2026-02-26
00842942017490PRIMEDpriMED Medical Products IncOXZ2025-11-25
10842942017497PRIMEDpriMED Medical Products IncOXZ2025-11-25
00842942017452PRIMEDpriMED Medical Products IncOXZ2025-11-12
90842942017455PRIMEDpriMED Medical Products IncOXZ2025-11-12
40852212003717ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-08-05
50852212003714ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-08-05
00842942001888PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942003806PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942014314PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942015267PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942015830PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942016059PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942016066PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942001885PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942003803PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942014311PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942015264PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942015837PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942016056PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942016063PRIMEDpriMED Medical Products IncOXZ2025-07-14
10686864058592Medicom SafeMaskAMD Medicom IncOXZ2025-01-23
20686864058599Medicom SafeMaskAMD Medicom IncOXZ2025-01-23
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
10810141931227VIVIT SupplyVivit Supply LLCOXZ2023-12-15
20810141931224VIVIT SupplyVivit Supply LLCOXZ2023-12-15