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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 4 of 12

Device	Model / Reference	Registries	Class	Status
KV-6 Suction Pump	200.5625	FDA UDI	Class II	Active
Vario 18 AC/DC	026.5120	FDA UDI	Class II	Active
Enteral Feeding	NGF60	FDA UDI	Class II	Unknown
Disposable Tubing	077.0952	FDA UDI	Class II	Active
Suction bag with solidifier 2.5l	077.0087	FDA UDI	Class II	Active
Accessories for Vario 18 pump	080.0009	FDA UDI	Class II	Active
Enteral Feeding	ENPV2665	FDA UDI	Class II	Active
Lid for safety Set with overflow protection device	077.0450	FDA UDI	Class II	Active
Suction Bag 2.5l	077.0086	FDA UDI	Class II	Active
Enteral Feeding	ENFPV2665LD	FDA UDI	Class II	Active
Enteral Feeding	ENPV-16-65	FDA UDI	Class II	Active
Enteral Feeding	TL-INT-10	FDA UDI	Class II	Active
Invia Liberty Carrying Case	087.0031	FDA UDI	Class II	Active
Angle piece	077.1015	FDA UDI	Class II	Active
AXS Universal Aspiration Tubing	077.0193	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2050	FDA UDI	Class II	Unknown
Disposable Specimen Cup	077.0564	FDA UDI	Class II	Active
PersonalFit Flex™ Double Pumping Kit	101045853	FDA UDI	Class II	Active
Overflow protection device	077.1021	FDA UDI	Class II	Active
ENFit Syringe 3ml	ENF03LD	FDA UDI	Class II	Active
Single set 5l, clampholder	077.0705	FDA UDI	Class II	Active
Enteral Feeding	7771	FDA UDI	Class II	Unknown
Symphony Double Pumping Kit	67099W	FDA UDI	Class II	Active
Invia Motion 60 Days	200.8591	FDA UDI	Class II	Active
Enteral Feeding	ENFPU3650	FDA UDI	Class II	Unknown
Diposable virus / odour Filter	101035289	FDA UDI	Class II	Active
Enteral Feeding	TL-002Y	FDA UDI	Class II	Active
Enteral Feeding	ENPU1650	FDA UDI	Class II	Active
Enteral Feeding	ENPV-42-80	FDA UDI	Class II	Active
Enteral Feeding	TL-070-18	FDA UDI	Class II	Active
Suction jar lid with conical patient connection and overflow device	080.0042	FDA UDI	Class II	Active
Invia Gauze Dressing Kit	200.8910	FDA UDI	Class II	Active
Silicone Tubing	077.0922	FDA UDI	Class II	Active
Thopaz tubing single, small connector	079.0023	FDA UDI	Class II	Active
Enteral Feeding	TL-CAP	FDA UDI	Class II	Unknown
Enteral Feeding	EB-060-14	FDA UDI	Class II	Active
Enteral Feeding	PLG-10	FDA UDI	Class II	Active
Enteral Feeding	ENPV1650C	FDA UDI	Class II	Active
Enteral Feeding	INT30	FDA UDI	Class II	Unknown
Safety device plugged into pump	077.0711	FDA UDI	Class II	Active
Enteral Feeding	TL004	FDA UDI	Class II	Active
Enteral Feeding	ENF001LD	FDA UDI	Class II	Active
Pump In Style Advanced	PNSA Metro Bag	FDA UDI	Class II	Active
Swing Maxi™ Hands-free	101046709	FDA UDI	Class II	Active
Enteral Feeding	ENFPV3650	FDA UDI	Class II	Unknown
Pump In Style Advanced	Pump In Style Advance Backpack	FDA UDI	Class II	Unknown
Enteral Feeding	INT-01	FDA UDI	Class II	Active
Enteral Feeding	NTL-30	FDA UDI	Class II	Active
Enteral Feeding	EB06016	FDA UDI	Class II	Active
Enteral Feeding	ENF07019	FDA UDI	Class II	Unknown

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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.