FDA.reportPublic FDA data

Invia Drain Adapter

Primary DI
07612367049542
Brand
Invia Drain Adapter
Company
Medela AG
Model
087.0024
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142626000Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty CanistersMedela AG2015-06-12OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612367049535PackageGS110In Commercial Distribution
07612367049542PackageGS116In Commercial Distribution
07612367041195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367049535076123670495357612367049535
07612367049542076123670495427612367049542
07612367041195076123670411957612367041195

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy tubing setA collection of sterile, flexible, plastic tubing and associated items (e.g., connectors, line clamp, negative pressure applicator pad, canister) intended to be used as part of a vacuum-assisted wound closure system; commonly known as negative pressure wound therapy (NPWT). It is designed to create an airtight connection between the open-cell foam dressing and drape at the wound site and the vacuum pump. The tubing allows negative pressure to be delivered to the wound site and provides a conduit to channel excess interstitial fluid, wound exudate, and infectious materials from the wound to the collection canister. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
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10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
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07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
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