FDA.reportPublic FDA data

Docking Station

Primary DI
07612367024426
Brand
Docking Station
Company
Medela AG
Model
079.0037
Device description
Docking Station for battery powered suction pump (e.g Invia Liberty or Thopaz+)
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)
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141553000
K142626000
K172145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141553000MEDELA THOPAZ+Medela AG2014-08-25BTA
K142626000Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty CanistersMedela AG2015-06-12OMP
K172145000Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPadMedela AG2018-05-09OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612367038904PackageGS120In Commercial Distribution
07612367024426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367038904076123670389047612367038904
07612367024426076123670244267612367024426

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Contacts#

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

Regulatory Flags#

DUNS number
488293218
Device count
1
Lot or batch
true
Serial number
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
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
10845854041413APEXConmed CorporationBTA2026-03-23
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
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
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
07612367038713Standard rail universal holderMedela AGOMP2024-06-03
07612367003575Change over valveMedela AGBTA2024-05-31
07612367011600Single set 2l, clampholderMedela AGBTA2024-05-31
108495540138623M™ V.A.C.®KCI USA, INC.OMP2024-03-05
108495540138793M™ V.A.C.®KCI USA, INC.OMP2024-03-05
108495540138863M™ V.A.C.®KCI USA, INC.OMP2024-03-05
10845854012963CONMEDConmed CorporationBTA2023-09-01
25060826400056NEXA DrapeNEXA MEDICAL LIMITEDOMP2023-08-30
25060826400063Nexa FoamNEXA MEDICAL LIMITEDOMP2023-08-30
07612367077972Invia Integrated Dressing Medela AGOMP2023-07-20
07612367077996Invia Integrated Dressing Medela AGOMP2023-07-20
07612367078009Invia Integrated Dressing Medela AGOMP2023-07-20
108495540140293M™ Veraflo™KCI USA, INC.OMP2023-07-12
108495540140363M™ Veraflo™KCI USA, INC.OMP2023-07-12
108495540140433M™ Veraflo™KCI USA, INC.OMP2023-07-12