FDA.reportPublic FDA data

Y-piece

Primary DI
07612367009928
Brand
Y-piece
Company
Medela AG
Model
077.1020
Device description
Y-piece
Published
2024-05-31
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
07612367009928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367009928076123670099287612367009928

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

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
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