FDA.reportPublic FDA data

TITANIUM VAC REG

Primary DI
08435510679033
Brand
TITANIUM VAC REG
Company
HERSILL SL
Model
PEDIATRIC CONT/INT
Catalog number
4349100
Device description
VACUSILL 3 REG PEDIATRIC CONTINUOUS INTERMITTENT
Published
2026-08-25
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
false

Product Codes#

Code, Name table
CodeName
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435510679033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435510679033084355106790338435510679033

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Regulatory Flags#

DUNS number
462032145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
08435510650872TITANIUM VAC REGSafety Trap PSU43502002026-08-25
08435510655150TITANIUM VAC REGPack 100 units particle filters Safety Trap43501052026-08-25
08435510679064TITANIUM VAC REGCONTINUOUS - INTERMITTENT43493002026-08-25
08435510679071TITANIUM VAC REGMEDIUM VACUUM43494002026-08-25
08435510679088TITANIUM VAC REGLOW VACUUM43492002026-08-25
08435510679101TITANIUM VAC REGCONT/INT DH*INT TRAP53493212026-01-07
08435510679767TITANIUM VAC REGCONT/INT CM*DM53493132026-01-07
08435510679774TITANIUM VAC REGCONT/INT OM*INT TRAP53493312026-01-07
08435510679866TITANIUM VAC REGCONT/INT PM*LG53493442026-01-07
08435510679873TITANIUM VAC REGCONT/INT DH*LG53493242026-01-07
08435510680039TITANIUM VAC REGPED CONT/INT DH*INT TRAP53491212026-01-07
08435510680046TITANIUM VAC REGLOW VAC DH*INT TRAP53492212026-01-07
08435510680053TITANIUM VAC REGMED VAC DH*INT TRAP53494212026-01-07
08435510678661CARE-E-VACCare-e-vac C/I - Reusable jar53202122025-01-17
08435510678678CARE-E-VACCare-e-vac Plus - Reusable jar53202142025-01-17
08435510678685CARE-E-VACCare-e-vac EMS - Reusable jar53202162025-01-17
08435510678692CARE-E-VACCare-e-vac EMS - Disposable jar53202172025-01-17
08435510678708CARE-E-VACCare-e-vac Plus - Disposable jar53202152025-01-17
08435510678715CARE-E-VACCare-e-vac C/I - Disposable jar53202132025-01-17
08435331771299V7V7 mx53202212018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435510650872TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510655150TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679064TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679071TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679088TITANIUM VAC REGHERSILL SLKDP2026-08-25
10197344144181MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-08-07
10197344144693MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144709MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144716MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144723MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144730MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144747MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144754MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144761MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144778MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144785MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144792MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144808MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144815MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144822MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146161MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146178MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146185MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146192MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146208MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146215MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146222MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147267MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147274MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147281MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24