FDA.reportPublic FDA data

Tubing 2M Single

Primary DI
07612367051132
Brand
Tubing 2M Single
Company
Medela AG
Model
080.0051
Device description
Tubing 2 M Single. Model No. MAJ-103 K. 3920733
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K150134000
K170329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150134000Basic, Dominant Flex, KV-6Medela AG2015-04-21QPB
K170329000Basic, Dominant FlexModela AG2017-03-24QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612367007061PackageGS150In Commercial Distribution
07612367010719PackageGS150Not in Commercial Distribution
07612367078214PackageGS115In Commercial Distribution
07612367051132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367007061076123670070617612367007061
07612367010719076123670107197612367010719
07612367078214076123670782147612367078214
07612367051132076123670511327612367051132

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.

Regulatory Flags#

DUNS number
488293218
Device count
1
Lot or batch
true
Expiration 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
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
07612367011372Single set 1lMedela AGQPB2024-05-31