FDA.reportPublic FDA data

Dolsure Medical

Primary DI
18936000172890
Brand
Dolsure Medical
Company
DOLSURE NUTRITION JOINT STOCK COMPANY
Model
N95/DM.01
Device description
Respirator is made of non-woven fabric with nose clip and elastic ear straps
Published
2021-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSHRespirator, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSHRespirator, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28936000172897PrimaryGS10
18936000172890Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2893600017289728936000172897
1893600017289018936000172890

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA 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 particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+842837975900xxx@xx.xx

Regulatory Flags#

DUNS number
555271663
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
28936000172897Dolsure MedicalN95/DM.012021-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086001469732RiskWise Health Kits RiskWise Supplies LLCMSH2026-05-18
00860014697333RiskWise Health Kits RiskWise Supplies LLCMSH2026-05-18
10326053123457Regard™Resource Optimization & Innovation, L.L.C.MSH2026-03-18
00817169029649Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMSH2026-03-05
00860014697302RiskWise SuppliesRiskWise Supplies LLCMSH2026-02-17
00860014697319RiskWise Supplies RiskWise Supplies LLCMSH2026-02-17
20680651492993HalyardO&M HALYARD, INC.MSH2025-09-30
20680651493006HalyardO&M HALYARD, INC.MSH2025-09-30
00639890596333RadnorLOUIS M. GERSON CO.MSH2025-04-14
00764423027777FastlineLOUIS M. GERSON CO.MSH2025-04-14
00850019086157Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096427MedavaLOUIS M. GERSON CO.MSH2025-04-14
00044585817301FastlineLOUIS M. GERSON CO.MSH2025-04-14
10850019086154Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096434MedavaLOUIS M. GERSON CO.MSH2025-04-14
00781311086104SAS Safety / GersonBunzl USA Holdings LLCMSH2025-04-04
10016659570150All Pro Bunzl USA Holdings LLCMSH2025-04-04
00850017658288SHIELDLWS HEALTH & SAFETY LLCMSH2025-02-11
00850017658264Lighthouse Worldwide Solutions IncLighthouse Worldwide Solutions, Inc.MSH2025-02-11
00850056748070FORWARD Enforcement Group Medical BagINTEGRATED MEDCRAFT LLCMSH2024-10-04
00628678429024VitacoreVitacore Industries IncMSH2024-09-05
00628678429031VitacoreVitacore Industries IncMSH2024-09-05
20197344019530MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
30197344019537MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
00852212003696ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
10852212003693ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
16946276000010Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
06946276000013Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
00044585333016GERSONLOUIS M. GERSON CO.MSH2024-01-12
00044585833301GERSONLOUIS M. GERSON CO.MSH2024-01-12