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ABBVIE INC.

United States·US-MF-000014055

Last updated May 25, 2026

Information

Country: United States
Address: 1 North Waukegan Road, North Chicago, Illinois, United States
Website: abbvie.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 800 255-5162
PRRC Contact: Andrew Aube
EUDAMED SRN: US-MF-000014055
FDA FEI Number: —
DUNS Number: 078458370

Catalogue (56)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
AbbVie ENFit Y-Connector 15 FR	0AV102-014-005	EUDAMED	Class IIa	Active
AbbVie ENFit NJ	0AV094-003	EUDAMED	Class IIa	Active
AbbVie ENFit NJ	0AV094-002	EUDAMED	Class IIa	Active
AbbVie ENFit Click Adaptor	0AV570-014-001	EUDAMED	Class IIa	Active
AbbVie ENFit Y-Connector 20 FR	0AV619-014-005	EUDAMED	Class IIa	Active
Manage-PD	MANAGE-PD	EUDAMED	Class I	Active
Abbvie Fitted Vest XXL	0AV551	FDA UDI	Class I	Active
Y-Connector for AbbVie PEG 15 FR	62924	FDA UDI	Class II	Active
AbbVie Snug Vest S	10633	FDA UDI	Class I	Active
Abbvie Fitted Vest XS	0AV551	FDA UDI	Class I	Active
AbbVie PEG	62910	FDA UDI	Class II	Active
AbbVie Lightweight Vest M	10634	FDA UDI	Class I	Active
Y-Connector for AbbVie PEG 20 FR	62926	FDA UDI	Class II	Active
AbbVie Click Adaptor	62922	FDA UDI	Class II	Active
Abbvie fitted belt	0AV600	FDA UDI	Class I	Active
AbbVie Cross Body Pack	10636	FDA UDI	Class I	Active
Abbvie Fitted Vest XXS	0AV551	FDA UDI	Class I	Active
AbbVie Hip Pack	10637	FDA UDI	Class I	Active
Abbvie Fitted Vest XXXL	0AV551	FDA UDI	Class I	Active
AbbVie PEG	62912	FDA UDI	Class II	Active
AbbVie Snug Vest XL	10633	FDA UDI	Class I	Active
Abbvie Fitted Vest Large	0AV551	FDA UDI	Class I	Active
AbbVie Lightweight Vest XL	10634	FDA UDI	Class I	Active
AbbVie Snug Vest L	10633	FDA UDI	Class I	Active
Fixation Plate for AbbVie PEG 15 FR	62920	FDA UDI	Class II	Active
Fixation Plate for AbbVie PEG 20 FR	62928	FDA UDI	Class II	Active
AbbVie Lightweight Vest S	10634	FDA UDI	Class I	Active
Abbvie Fitted Vest Small	0AV551	FDA UDI	Class I	Active
AbbVie NJ	62903	FDA UDI	Class II	Active
AbbVie Chest Pack	10635	FDA UDI	Class I	Active
Abbvie Fitted Vest Medium	0AV551	FDA UDI	Class I	Active
AbbVie J	AV062	FDA UDI	Class II	Active
Abbvie Fitted Vest XXXS	0AV551	FDA UDI	Class I	Active
AbbVie Snug Vest XS	10633	FDA UDI	Class I	Active
Skyrizi	19558595	FDA UDI	Class II	Active
AbbVie Lightweight Vest XS	10634	FDA UDI	Class I	Active
AbbVie J	62918	FDA UDI	Class II	Active
AbbVie Lightweight Vest XXL	10634	FDA UDI	Class I	Active
Skyrizi	19558594	FDA UDI	Class II	Active
AbbVie Snug Vest XXL	10633	FDA UDI	Class I	Active
AbbVie Lightweight Vest L	10634	FDA UDI	Class I	Active
Abbvie Fitted Vest XL	0AV551	FDA UDI	Class I	Active
AbbVie Snug Vest M	10633	FDA UDI	Class I	Active
AbbVie Fixation Plate 20 FR	062928-002	EUDAMED	Class I	Active
AbbVie PEG	K142793	FDA 510(k)	Class II	Active
Natrelle 133S Tissue Expanders	K254126	FDA 510(k)	U	Active
Abbvie Nj	K133129	FDA 510(k)	Class II	Active
Abbvie Peg	K133087	FDA 510(k)	Class II	Active
AbbVie NJ	K142792	FDA 510(k)	Class II	Active
AbbVie J	K142816	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Allergan Pharmaceuticals International Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (4)

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
Apr 27, 2017	Z-2176-2017	—	terminated	—
Apr 27, 2017	Z-2178-2017	—	terminated	PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
Apr 27, 2017	Z-2177-2017	—	terminated	PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
Nov 22, 2016	Z-0786-2017	—	terminated	AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.