FDA.reportPublic FDA data

V7

Primary DI
08435331771312
Brand
V7
Company
HERSILL SL
Model
V7 plus b
Catalog number
5320223
Device description
Portable suction unit
Published
2018-09-21
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
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093241000V7 PORTABLE SUCTION UNITSHersill, S.L.2010-04-27BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435331771312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435331771312084353317713128435331771312

GMDN Terms#

Term, Definition table
TermDefinition
Emergency airway clearance suction system, electricA portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.

Regulatory Flags#

DUNS number
462032145
Device count
1
Lot or batch
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
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
08435331771305V7V7 plus b emergency53202222018-09-21
08435331771329V7V7 plus ac53202242018-09-21
08435331739619V7V7 G, jar 1PC53202712018-01-31
08435331770575V7V7 G53202202018-01-31

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Primary DI, Brand, Company table
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00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
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00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26
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00860014577529GROWNSYOak Tech LLCBTA2025-08-26
06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115VArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
00810149097997R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-23
00810149097973R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
00810149097980R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
06975740361558MomcozyShenzhen Root Innovation Technology Co., Ltd.BTA2025-05-20
06978331170218BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
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