Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017202422

FEI Number

3017202422

Entity Name

Flexicare Lanka (Pvt) Ltd

City/State/Country

Bandaragama Western, LK

Establishment Address

382/x, Kumbuka Road, Raigama, Bandaragama Western 12530, LK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FLEXICARE MEDICAL LTD. (Owner Number: 8021995)

Owner / Operator Contact Address

CYNON VALLEY BUSINESS PARK, MOUNTAIN ASH, GB-RCT CF45 4ER, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FLEXICARE SUCTION TUBING, CONTINUOUS COIL - NON STERILE FLEXICARE SUCTION TUBES - STERILE MWPFM STD ATS CLAM (TRI-ANIM) MWPFM STD ATS CLAM MWPFM STD ATS ATM SINGLE MW STD ATS (MEDLINE) 12X20 BOX Flexicare Breathing Filters Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP Nose Clip Flexicare High Flow Nasal Cannula Veoflo High Flow Nasal Cannula Nioflo Oxygen Cannula Flexicare Nasal Cannula Veoflo Pro High Flow Nasal Cannula Nasal Cannula CO2 monitoring VENTICAIRE RESERVOIR BAGS IN-CHECK ORAL ATM VENTICAIRE VENTURI MASK VENTIMASK VENTURI MASKS VENTICAIRE FLEXICARE PRESSURE RELIEF VALVE FLEXICARE APL VALVE FLEXICARE OXYGEN TUBING MWPFM L/R ATS ATM SINGLE MWPFM AFSLOW RANGE ATS MW AFS ATS (MEDLINE) 12X30 BOX Flexicare Connector Flexible Catheter Mount Kingsystems Medisize Breathing Circuit Adult breathing circuit pediatric Medisize Breathing Circuit Pediatric breathing circuit adult Medisize Breathing Circuit Neonatal breathing circuit neonatal VENTICAIRE BREATHING CIRCUITS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2015-08-12
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2023-07-24
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2010-05-12
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2017-07-25
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2023-10-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2007-01-17
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-04-17
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2006-08-30
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2023-07-24
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2006-08-30
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2007-01-17
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2023-07-24
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2007-01-18
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-08-30

Official Correspondent

Rebecca Funston

US Agent Details

ASHLEY MOTAMEDI Email: ashley.motamedi@flexicare.com Phone: (949) 4509999

Related Public Records

Same Entity

FLEXICARE MEDICAL LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3006061749	FLEXICARE MEDICAL (DONGGUAN) LTD.	DONGGUAN CITY Guangdong, CN
9610639	CLEMENT CLARKE INTL., LTD.	Mountain Ash Rhondda Cynon Taff, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017202422. Last updated year: 2026. Please use registration number 3017202422 when referencing this establishment in official correspondence.