FDA.reportPublic FDA data

Serial connection, patient

Primary DI
07612367023290
Brand
Serial connection, patient
Company
Medela AG
Model
077.0158
Device description
Tubing for collection system
Published
2017-06-07
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
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
07612367023290PrimaryGS10
07612367051583Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367023290076123670232907612367023290
07612367051583076123670515837612367051583

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. 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
100
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
05060461080954Venbaby Nasal Aspirator and Saline Bundle DT10VENTURE HEALTHCARE LTDBTA2026-10-29
05060461080961Venbaby Nasal Aspirator & Saline BundleVENTURE HEALTHCARE LTDBTA2026-10-29
03701068807651FAT HARVESTING CANNULAAESTHETIC GROUPQPB2026-10-28
00810130457267Medco ManufacturingMedco Manufacturing LLCMUU2026-10-23
08800028800284SonoSculptNewpongQPB2026-10-13
06978731720013Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720020Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720037Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720044Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720051Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720068Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720075Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720082Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720099Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720105Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720112Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
07640306733177LipoSurg Artist Control UnitNouvag AGQPB2026-09-18
07640306733184LipoSurg Artist Handpiece S3Nouvag AGQPB2026-09-18
07640306733207LipoSurg Foot ControllerNouvag AGQPB2026-09-18
07640306733245LipoSurg Power Control UnitNouvag AGQPB2026-09-18
07640306733429LipoSurg Artist Standard SetNouvag AGQPB2026-09-18
07640306733436LipoSurg Power Standard SetNouvag AGQPB2026-09-18
B382SD6211530Surgical DirectSurgical Direct, Inc.MUU2026-08-03
06970289030866foreverlittleHetaida Technology Co., LtdBTA2026-07-28
00842429118689MV Flow Aspiration PumpMicrovention, Inc.BTA2026-07-15
00607151050627AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050634AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050641AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 1 ringAPYX MEDICAL CORPORATIONQPB2026-06-26
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04