Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017231740

FEI Number

3017231740

Entity Name

Avaline Medical Limited Liability Company

City/State/Country

Lakewood, NJ, US

Establishment Address

1965 Swarthmore Ave, Suite 8, Lakewood, NJ 08701, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Avaline Medical NJ Limited Liability Company (Owner Number: 10077314)

Owner / Operator Contact Address

1965 Swarthmore Ave Suite 8, Lakewood, NJ 08701, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vakly Paper Surgical Tape Vakly Elastic Tape Vakly Adhesive Bandage Vakly Surgical Tape Vakly Plastic Tape Vakly Sterile Packing Strips Vakly Toothbrush Manual Vakly Denture Brush Vakly Refillable Ice Bags Vakly Disposable Souffle Cups Vakly Combat Pressure Bandage Vakly Bandages Vakly Microscope Slides Vakly Disposable Tourniquet Vakly Cotton Tipped Applicators Vakly Tubular Stockinette Compression Stockings Vakly Cotton Gauze Pads Vakly Krinkle Gauze Vakly Split Drain Sponge Vakly Combine Abdominal Pads Vakly Non-Woven Gauze Dressing Sponge Pads Vakly Stretch Gauze Vakly Sterile Gauze Pads Vakly Bedpans Vakly Trauma Sheers Vakly Adhesive Bandages Vakly Commode Liner With Absorbent Pad Vakly Stretcher Sheets Vakly Tray Sleeve Vakly TIssue/Poly Pillowcases Vakly Disposable Underpads Vakly Exam Table Paper Vakly Drape Sheet Vakly Urinal Vakly Ear Bulb Vakly Unna Boot Bandage Vakly Triangular Bandages Vakly Elastic Bandage Vakly Combat Pressure Bandage Vakly Cohesive Wrap Vakly Butterfly Wound Closures Vakly Knit Underwear Vakly Reusable Underpad Vakly Incontinence Liner-Postpartum Maternity Pad Adult Vinyl Waterproof Pull-On Pans Booster Liner Pads Vakly Foam Heel Protectors Vakly Knit Heel and Elbow Protectors Vakly Specimen Collector Pan Vakly Strainer/Kidney Stone Collector Vakly Triangular Intake/Output Laboratory Container Vakly Specimen Cups Vakly Sterile Specimen Cups Vakly Dental Bibs Vakly Paper Tray Cover Vakly Pill Crusher Pouches Vakly Dental Cotton Balls Large 1 lb White 100% Cotton Roll

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-08-20
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-07-25
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-03-30
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2024-06-05
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2020-08-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-08-20
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2021-09-14
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-06-21
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-08-20
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2020-08-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-08-20
FOB	Bedpan	General Hospital	Class 1	880.6730	2020-08-20
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-08-20
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2022-06-16
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-08-20
FNP	Urinal	General Hospital	Class 1	880.6730	2020-08-20
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2021-09-14
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2020-08-20
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2020-08-20
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2020-08-20
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-08-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-08-20
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2020-08-20
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2020-08-20
EFN	Cotton, Roll	Dental	Class 1	872.6050	2020-08-20

Official Correspondent

Steven Zeldes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avaline Medical NJ Limited Liability Company

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017231740. Last updated year: 2026. Please use registration number 3017231740 when referencing this establishment in official correspondence.