Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013034812

FEI Number

3013034812

Entity Name

REDICARE LLC

City/State/Country

Congers, NY, US

Establishment Address

225 N Route 303 Ste 101, Congers, NY 10920, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Redicare LLC (Owner Number: 10053279)

Owner / Operator Contact Address

225 N Route 303, Suite 101, Congers, NY 10920, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tweezer/Forcep Redicare Sterile Gauze Pads Redicare Non Adherent Pads Redicare Non Sterile Gauze Wrap RediWipes Alcohol Wipes Resuscitation Kit Blood Borne Pathogen Kit Burn Kit Basic First Aid Kit Overdose Response Kit RediWipes Antiseptic Wipes RediSplint Aluminum Foam Splint Redicare Occlusive Chest Seal Basic First Aid Kit Resuscitation Kit Latex-Free Disposable Emergency Tourniquet Redicare Adhesive Bandages Blood Borne Pathogen Kit Redicare Instant Ice Pack Redicare Instant Cold Spray Redicare Trauma Shears Foil Emergency Blanket

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-11-18
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-01-05
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2017-07-06
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2019-03-07
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-07-06
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2016-11-16
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-05-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-12-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-12-23
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2019-03-07
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2017-01-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-01-05
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2019-03-07
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2017-02-24
MLY	Vapocoolant Device	Unknown	Class U	N/A	2023-08-29
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-12-06
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-05-09

Official Correspondent

Steve Pontefract

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Redicare LLC

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03

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 3013034812. Last updated year: 2026. Please use registration number 3013034812 when referencing this establishment in official correspondence.