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Medela LLC

Last updated September 17, 2026

Information

Country: US
Address: 1101 CORPORATE DR., MCHENRY, IL, 60050
Website: medela.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-435-8316
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1419937
DUNS Number: 052002029

Catalogue (579)

Page 11 of 12

Device	Model / Reference	Registries	Class	Status
Pump In Style® Hands-free Resupply Kit	101046872	FDA UDI	Class II	Active
Coupling piece 5mm	077.0161	FDA UDI	Class II	Active
Enteral Feeding	TL002Y	FDA UDI	Class II	Active
Enteral Feeding	ENFDUALCAPCNSLD	FDA UDI	Class II	Unknown
Basic portable	Basic	FDA UDI	Class II	Active
Lactina Breast pump kit- Sterile	67394S	FDA UDI	Class II	Active
Enteral Feeding	EB-060-18	FDA UDI	Class II	Active
Enteral Feeding	PLG-30	FDA UDI	Class II	Active
Double conical coupling piece	077.1017	FDA UDI	Class II	Active
Enteral Feeding	EB-060-15	FDA UDI	Class II	Active
Invia Motion 15 Days Kit 10 x 25 cm	101045893	FDA UDI	Class II	Active
Vario 18 AC	026.0007	FDA UDI	Class II	Active
Enteral Feeding	TL06018	FDA UDI	Class II	Active
Suction Jar Polysulfone, 1l	077.0110	FDA UDI	Class II	Active
Tubing holder left side	077.0751	FDA UDI	Class II	Active
Disposable Overlfow Protection / Virus Odour Filter	101035286	FDA UDI	Class II	Active
Enteral Feeding	ENFPV1650LD	FDA UDI	Class II	Active
Enteral Feeding	INT01	FDA UDI	Class II	Active
Disposable Overflow Protection / Bacteria filter	077.0577	FDA UDI	Class II	Active
Diposable Overflow Protection / Virus filter	101035263	FDA UDI	Class II	Active
Enteral Feeding	ENPV-16-80	FDA UDI	Class II	Active
Hands-free Breast shields, 27mm	101045783	FDA UDI	Class II	Active
Enteral Feeding	ENFMEDCAP	FDA UDI	Class II	Unknown
Medela Basic 30 And Dominant 50 Suction Pumps, Models 037, 057	K021368	FDA 510(k)	Class II	Active
Duo Hands-free Breast Pump	K232608	FDA 510(k)	Class II	Active
Medela Thopaz, Model 200 0288	K080212	FDA 510(k)	Class II	Active
Medela Electric Breast Pump	K801862	FDA 510(k)	Class II	Active
Medela Apgar Timer	K834129	FDA 510(k)	Class I	Active
Medela Battery Operated Breast Pump	K901344	FDA 510(k)	Class II	Active
Invia Ease Negative Pressure Wound Therapy (NPWT) System	K214112	FDA 510(k)	Class II	Active
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail	K161725	FDA 510(k)	Class II	Active
Breast Shells	K923577	FDA 510(k)	Class I	Active
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply	K161128	FDA 510(k)	Class II	Active
Solo, Swing Maxi	K210759	FDA 510(k)	Class II	Active
Medela Low Dose Enteral Syringe	K161811	FDA 510(k)	Class II	Active
Invia Endure Negative Pressure Wound Therapy System	K141926	FDA 510(k)	Class II	Active
Medela Thopaz	K130210	FDA 510(k)	Class II	Active
Medela Vario Suction Pumps	K061435	FDA 510(k)	Class II	Active
Medela Breast-Pump Lactina	K875300	FDA 510(k)	Class II	Active
Pump In Style® Pro+	K253498	FDA 510(k)	Class II	Active
Medela Swing Breast Pump	K053052	FDA 510(k)	Class II	Active
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large	K151261	FDA 510(k)	Class II	Active
Medela Invia Wound Therapy	K080357	FDA 510(k)	Class II	Active
Basic, Median, Dominant, And Vario	K983552	FDA 510(k)	Class II	Active
Medela Symphony Breast Pump, Model 024	K020518	FDA 510(k)	Class II	Active
Medelas Breast Pump	K950750	FDA 510(k)	Class II	Active
Invia 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 FitPad	K172145	FDA 510(k)	Class II	Active
Basic, Dominant Flex, KV-6	K150134	FDA 510(k)	Class II	Active
Basic And Dominant Flex Suction Pumps	K130123	FDA 510(k)	Class II	Active
Medela Vario 8/18/Ci Secretion & Surgical Aspirator	K061205	FDA 510(k)	Class II	Active

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 2, 2019	Z-0773-2020	—	terminated	Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Dec 5, 2018	Z-2061-2019	—	terminated	The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
Feb 7, 2018	Z-2528-2018	—	terminated	Device may display a battery missing error.
Jul 27, 2011	Z-3172-2011	—	terminated	Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain".
May 18, 2011	Z-2553-2011	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Apr 4, 2011	Z-2386-2011	—	terminated	The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.
Jan 10, 2011	Z-1224-2011	—	terminated	The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.
Aug 6, 2010	Z-2483-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010	Z-2484-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010	Z-2486-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010	Z-2485-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Mar 15, 2010	Z-1442-2010	—	terminated	The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.