FDA.reportPublic FDA data

TITANIUM VAC REG

Primary DI
08435510680039
Brand
TITANIUM VAC REG
Company
HERSILL SL
Model
PED CONT/INT DH*INT TRAP
Catalog number
5349121
Device description
VACUSILL 3 REG PEDIATRIC CONTINUOUS INTERMITTENT + DH WALL CONNECTION + SAFETY TRAP
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08435510680039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435510680039084355106800398435510680039

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
462032145
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
08435331771305V7V7 plus b emergency53202222018-09-21
08435331771312V7V7 plus b53202232018-09-21
08435331771329V7V7 plus ac53202242018-09-21
08435331739619V7V7 G, jar 1PC53202712018-01-31
08435331770575V7V7 G53202202018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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