FDA.reportPublic FDA data

DIMAR

Primary DI
28056814676265
Brand
DIMAR
Company
HMC PREMEDICAL SPA
Model
700/7319US
Catalog number
700/7319US
Device description
"DIMAX ZERO" TOTAL FACE MASK FOR NIV SINGLE USE SIZE XXL
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
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

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
28056814676265PackageGS15In Commercial Distribution
08056814676261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2805681467626528056814676265
08056814676261080568146762618056814676261

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
08056814676360DIMAR700/7309US700/7309US2025-03-20
28056814676371DIMAR700/7310US700/7310US2025-03-20
28056814676388DIMAR700/7311US700/7311US2025-03-20
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
00814747025239Novaplus Full Face AAV Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025246Novaplus Full Face AAV Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025253Novaplus Full Face AAV Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025260Novaplus Full Face AAV Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00814747025277Novaplus Full Face Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025291Novaplus Full Face Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025307Novaplus Full Face Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00198843006454LTVZoll Medical CorporationCBK2026-09-18
00198843006492LTVZoll Medical CorporationCBK2026-09-18
00198843006515LTVZoll Medical CorporationCBK2026-09-18
00198843006539LTVZoll Medical CorporationCBK2026-09-18
00198843007352LTVZoll Medical CorporationCBK2026-09-18
00198843002913bellavistaZoll Medical CorporationCBK2026-07-22
00198843002920bellavistaZoll Medical CorporationCBK2026-07-22
00198843002852bellavistaZoll Medical CorporationCBK2026-07-10
00198843002869bellavistaZoll Medical CorporationCBK2026-07-10
00198843002876bellavistaZoll Medical CorporationCBK2026-07-06
00198843001145bellavistaZoll Medical CorporationCBK2026-06-24
00198843001152bellavistaZoll Medical CorporationCBK2026-06-24
00848530108816Breathing CircuitSunset Healthcare Solutions, Inc.CBK2026-04-17
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06