FDA.reportPublic FDA data

Foot vacuum regulator

Primary DI
07612367003933
Brand
Foot vacuum regulator
Company
Medela AG
Model
077.0731
Device description
Foot vacuum Regulator for adjustment of vacuum by foot for Dominant Flex and Basic
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130123000
K150134000
K170329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130123000BASIC AND DOMINANT FLEX SUCTION PUMPSMedela AG2013-10-11BTA
K150134000Basic, Dominant Flex, KV-6Medela AG2015-04-21QPB
K170329000Basic, Dominant FlexModela AG2017-03-24QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612367003933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367003933076123670039337612367003933

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, line-poweredAn assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-877-735-1626info-healthcare@medela.com

Regulatory Flags#

DUNS number
488293218
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612367041201Invia Liberty Y-Connector with quick connector087.00232016-10-03
07612367016940Invia Liberty Carrying Case087.00312024-10-11
07612367060509Invia Motion Carrying Case087.40032024-10-11
07612367004176Disposable bacteria filter077.05742016-10-03
07612367004190Disposable bacteria /odour filter077.05762016-10-03
07612367011341Disposable Overflow Protection / Bacteria filter 077.05772016-10-03
07612367011365Filter paper for autoclavable bacteria filter077.10142021-09-01
07612367014250Disposable overflow protection /bacteria/odour filter077.00922016-10-03
07612367064712Disposable Overflow Protection / Bacteria Odour Filter1010352852019-04-30
07612367064743Disposable Overlfow Protection / Virus Odour Filter1010352862019-04-30
07612367064774Disposable Overflow Protection / Virus Odour Filter1010352872019-04-30
07612367064835Disposable virus filter 1010352842019-04-30
07612367064866Disposable virus / odour filter1010352882019-04-30
07612367064897Diposable virus / odour Filter1010352892019-04-30
07612367080569Filter paper for autoclavable bacteria filter077.10142021-09-01
07612367010924Filter, particle, Medela connection077.05822024-05-31
07612367011617Disposable tube 200cm077.09632024-05-31
07612367005104Angle piece 077.10152016-10-03
07612367005111Angle piece077.10162016-10-03
07612367016131Vario 18 AC/DC026.51202023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
10845854041413APEXConmed CorporationBTA2026-03-23
08435510678661CARE-E-VACHERSILL SLBTA2025-01-17
08435510678678CARE-E-VACHERSILL SLBTA2025-01-17
08435510678685CARE-E-VACHERSILL SLBTA2025-01-17
08435510678692CARE-E-VACHERSILL SLBTA2025-01-17
08435510678708CARE-E-VACHERSILL SLBTA2025-01-17
08435510678715CARE-E-VACHERSILL SLBTA2025-01-17
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGQPB2024-05-31
07612367003551Quiver 280mmMedela AGQPB2024-05-31
07612367003568Quiver 480mmMedela AGQPB2024-05-31
07612367003575Change over valveMedela AGBTA2024-05-31
07612367003575Change over valveMedela AGQPB2024-05-31
07612367003698Overflow protection deviceMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGQPB2024-05-31
07612367003742Safety Set for railholderMedela AGQPB2024-05-31
07612367003896Tubing holder left sideMedela AGQPB2024-05-31
07612367003902Tubing holder right sideMedela AGQPB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGQPB2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGQPB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGQPB2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGQPB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGQPB2024-05-31
07612367008242Double conical coupling pieceMedela AGQPB2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGQPB2024-05-31
07612367009928Y-pieceMedela AGQPB2024-05-31
07612367010924Filter, particle, Medela connectionMedela AGQPB2024-05-31
07612367011204Vario Filter set, bacteria & overflowMedela AGQPB2024-05-31