Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611594

FEI Number

3002806436

Entity Name

AVENT S. de R.L. de C.V.

City/State/Country

NOGALES Sonora, MX

Establishment Address

CIRCUITO INDUSTRIAL NO.40, COLONIA OBRERA, NOGALES Sonora CP 84048, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Avanos Medical, Inc. (Owner Number: 2022573)

Owner / Operator Contact Address

5405 Windward Parkway, --, Alpharetta, GA 30004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Toothbrush KimVent Oral Care SOFSWAB DENTASWAB Dentaswab Busse EpiGlide Loss of Resistance LOR Syringe enteral feeding tubes Container, IV Endoscopic Accessories Cytology Brush Endoscope Cleaning Brush ANTI-FOG KIT Syringe CORTRAK* 2 Equilateral Enteral Access System NeoMed Sampling Straw MIC-KEY "G" LOW PROFILE G MIC-KEY MIC and MIC-KEY G-Tube and Extension Sets Halyard TRACH CARE TRACHEAL SUCTION SYSTEM KimVent Closed Suction System BALLARD Liberator/Restore Ballard Single Dose Vials, 0.9% Sodium Chloride Solution Ballard Metered Dose Inhaler (MDI) Adapter Gastropexy Kit and Dilator NeoConnect Enteral Extension Set with ENFit connector NeoConnect Sampling Straw with ENFit Connector NeoMed Enteral Only Extension Set BD Epilor Plastic LOR 7 mL with luer slip tip syringe 220344 220343 220542 220472 220462 220513NR 220573 220508NR 220539 220481NZ 220541 220507 220528 220404 220513 220576 220466 220574 220481ANR 220509NR 220561 220316 220266MIL 220481ZNR 220342 220477 220537 220405 220509 220472NR 220471 220463 220563 220471NR 220575 220473NR 220481AUS 220568 220507NR 220562 220532 220577 220508 220560 220451 220473 220493 220490NR 220491NR 220489NR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2014-10-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-07-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-07-06
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-08-17
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2022-02-16
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-09-19
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2014-10-15
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2014-10-15
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2014-10-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2006-08-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-10-31
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-08-01
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-05-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2013-06-28
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2017-07-06
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2020-01-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2006-04-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-08-01
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2009-10-30
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2007-08-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-07-06
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-09-19
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-08-01
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	Class 2	876.5980	2010-01-15
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-03-17
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2008-05-08
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-11-04
PIO	Enteral Specific Transition Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-08-07
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-01-28
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2014-10-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-07-03
OFQ	Anesthesia Kit	Anesthesiology	Class 2	868.5120	2021-06-29

Official Correspondent

No official correspondent registered.

US Agent Details

Amy Winegarden Business: Avanos Medical, Inc. Email: RegulatoryAffairsNA@avanos.com Phone: (844) 4282667

Related Public Records

Same Entity

Avanos Medical, 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
3011270181	Avanos Medical, Inc.	Alpharetta, GA, US
9680425	Avent S. de R.L. de C.V.	TIJUANA Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0005-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611594. Last updated year: 2026. Please use registration number 9611594 when referencing this establishment in official correspondence.