Is this your brand? Sign in to claim ownership.

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 6 of 12

Device	Model / Reference	Registries	Class	Status
Enteral Feeding	EB06018	FDA UDI	Class II	Active
Enteral Feeding	ENPU1680	FDA UDI	Class II	Active
Invia Motion Carrying Case	087.4003	FDA UDI	Class II	Active
Silicone Tubing	077.0185	FDA UDI	Class II	Active
Invia Motion Canister /Tubing Set	200.7917	FDA UDI	Class II	Active
Suction jar, 1 lt	080.0023	FDA UDI	Class II	Active
Enteral Feeding	ENPV-26-80	FDA UDI	Class II	Active
Serial connection, patient	077.0160	FDA UDI	Class II	Active
Vario 18 c/i AC/DC	026.8122	FDA UDI	Class II	Active
Enteral Feeding	ENFPU1680LD	FDA UDI	Class II	Active
Freestyle Breastpump, Deluxe Set	67060	FDA UDI	Class II	Active
Syphony Breat pump kit- Sterile	67399S	FDA UDI	Class II	Active
Invia Foam Dressing Kit	200.8908	FDA UDI	Class II	Active
Enteral Feeding	ENFPU1665LD	FDA UDI	Class II	Active
Suction jar 2.5l, polycarbonate, for disposable collection system	077.0085	FDA UDI	Class II	Active
Coupling piece 90°	077.1019	FDA UDI	Class II	Active
Enteral Feeding	ENFMALELD	FDA UDI	Class II	Active
Symphony and Lactina Breast pump kit	67116	FDA UDI	Class II	Active
Pump In Style® Hands-free Resupply Kit	101046874	FDA UDI	Class II	Active
Enteral Feeding	ENPV1665	FDA UDI	Class II	Active
Freestyle Flex	101037980	FDA UDI	Class II	Active
Thopaz disposable canister with solidifier, 0.8l	079.0017	FDA UDI	Class II	Active
J&J DePuy Synthes convenience kit	101043438	FDA UDI	Class II	Active
Enteral Feeding	ENPU2040	FDA UDI	Class II	Active
Enteral Feeding	INT10	FDA UDI	Class II	Unknown
Enteral Feeding	ENFGF30	FDA UDI	Class II	Unknown
Suction jar 1.5l	077.0082	FDA UDI	Class II	Active
Invia Liberty Y-Connector with quick connector	087.0023	FDA UDI	Class II	Active
Enteral Feeding	101034138	FDA UDI	Class II	Active
Thopaz Tubing Extension, 1 Line, sterile	101039326	FDA UDI	Class II	Active
Enteral Feeding	ENFMALE	FDA UDI	Class II	Unknown
AXS Universal Liner Set with Solidifier	101035340	FDA UDI	Class II	Active
Disposable Specimen Cup	077.0562	FDA UDI	Class II	Active
Enteral Feeding	TLINT60	FDA UDI	Class II	Unknown
Colostrum Collector Sterile	101044659	FDA UDI	Class II	Active
AXS Universal Liner Set	077.0194	FDA UDI	Class II	Active
Enteral Feeding	ENPV3650	FDA UDI	Class II	Active
Thopaz Tubing Extension, 3 Lines, sterile	101039327	FDA UDI	Class II	Active
Enteral Feeding	ENPU42100	FDA UDI	Class II	Active
Enteral Feeding	ENPU2050	FDA UDI	Class II	Active
Enteral Feeding	ENFPU4280	FDA UDI	Class II	Unknown
Solo™ Hands-free	101047309	FDA UDI	Class II	Active
Single set 2l, clampholder	077.0702	FDA UDI	Class II	Active
KV-6 Suction Pump	200.5625	FDA UDI	Class II	Active
Enteral Feeding	TL-002	FDA UDI	Class II	Active
Thopaz disposable canister 0.8l	079.0016	FDA UDI	Class II	Active
Enteral Feeding	ENFDUALCAPCLD	FDA UDI	Class II	Unknown
Enteral Feeding	TL-INT-05	FDA UDI	Class II	Active
Invia Integrated Dressing	101035699	FDA UDI	Class II	Active
Pump In Style	101041265	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.