Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012441529

FEI Number

3012441529

Entity Name

AbbVie Ireland NL B.V. Ballytivnan

City/State/Country

Sligo, IE

Establishment Address

Ballytivnan, Sligo N/A, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AbbVie Inc. (Owner Number: 10046068)

Owner / Operator Contact Address

1 N. Waukegan Rd, J23, North Chicago, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AbbVie NJ Coolsculpting System Coolsculpting System GID 700; Revolve; The Revolve System Coolsculpting System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-02-04
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2022-04-12
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2022-04-12
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	Class 2	878.5040	2021-08-13
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2022-04-12

Official Correspondent

Michael McCoy

US Agent Details

Yvonne Lozano Business: ABBVIE INC. Email: yvonne.lozano@abbvie.com Phone: (847) 9380757

Related Public Records

Same Entity

AbbVie Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002807401	AbbVie Deutschland GmbH & Co.KG	Ludwigshafen Rhineland-Palatinate, DE
3011299837	AbbVie US LLC	North Chicago, IL, US
3010757606	AbbVie Inc	North Chicago, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

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3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012441529. Last updated year: 2026. Please use registration number 3012441529 when referencing this establishment in official correspondence.