FDA.reportPublic FDA data

Large lid with conical patient connection 6–10 mm

Primary DI
07612367002806
Brand
Large lid with conical patient connection 6–10 mm
Company
Medela AG
Model
077.0420
Device description
Large lid with conical patient connection 6–10 mm for reusable collection system
Published
2016-10-24
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)
HDBExtractor, Vacuum, Fetal
MUUSystem, Suction, Lipoplasty
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
HDBExtractor, Vacuum, FetalObstetrics/Gynecology2
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130123000
K150134000
K153663000
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
K153663000Vario 8/18/ciMedela AG2016-05-18BTA
K170329000Basic, Dominant FlexModela AG2017-03-24QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612367037952PackageGS132In Commercial Distribution
07612367002806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367037952076123670379527612367037952
07612367002806076123670028067612367002806

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

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
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGHDB2024-05-31
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGQPB2024-05-31
07612367003551Quiver 280mmMedela AGQPB2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGHDB2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGHDB2024-05-31
07612367003568Quiver 480mmMedela AGQPB2024-05-31
07612367003575Change over valveMedela AGQPB2024-05-31
07612367003575Change over valveMedela AGBTA2024-05-31
07612367003698Overflow protection deviceMedela AGHDB2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGHDB2024-05-31
07612367003742Safety Set for railholderMedela AGQPB2024-05-31
07612367003742Safety Set for railholderMedela AGHDB2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGQPB2024-05-31
07612367003896Tubing holder left sideMedela AGHDB2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGQPB2024-05-31
07612367003902Tubing holder right sideMedela AGHDB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGMUU2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGHDB2024-05-31