FDA.reportPublic FDA data

DIMAR

Primary DI
28056814676388
Brand
DIMAR
Company
HMC PREMEDICAL SPA
Model
700/7311US
Catalog number
700/7311US
Device description
"DIMAX" TOTAL FACE MASK FOR NIV SINGLE USE SIZE L
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232836000Family of DIMAR DMAX NIV masksDimar S.P.A.2024-08-14CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28056814676388PackageGS15In Commercial Distribution
08056814676384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2805681467638828056814676388
08056814676384080568146763848056814676384

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39 053522704giovanna.gavioli@hmcgroup.it

Regulatory Flags#

DUNS number
339002025
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056814676223DIMAR700/7315US700/7315US2025-03-20
08056814676247DIMAR700/7317US700/7317US2025-03-20
08056814676254DIMAR700/7318US700/7318US2025-03-20
08056814676261DIMAR700/7319US700/7319US2025-03-20
08056814676377DIMAR700/7310US700/7310US2025-03-20
08056814676384DIMAR700/7311US700/7311US2025-03-20
08056814676391DIMAR700/7312US700/7312US2025-03-20
08056814676407DIMAR700/7313US700/7313US2025-03-20
28056814676227DIMAR700/7315US700/7315US2025-03-20
08056814676230DIMAR700/7316US700/7316US2025-03-20
28056814676241DIMAR700/7317US700/7317US2025-03-20
28056814676258DIMAR700/7318US700/7318US2025-03-20
28056814676265DIMAR700/7319US700/7319US2025-03-20
08056814676360DIMAR700/7309US700/7309US2025-03-20
28056814676371DIMAR700/7310US700/7310US2025-03-20
28056814676395DIMAR700/7312US700/7312US2025-03-20
28056814676401DIMAR700/7313US700/7313US2025-03-20
18053676290014B-SmartBS015-302016-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344011858HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011865HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011872HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
00848530109677CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00198843003606Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003613Infant Flow™Zoll Medical CorporationBZD2026-08-14
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00198843003651Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003668Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003675Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003682Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003699Infant Flow™Zoll Medical CorporationBZD2026-08-14
06970819423212RXiBreeze PAP SystemResvent Medical Technology Co., Ltd.BZD2026-08-14
00850088881097MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881103MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14