Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010838917

FEI Number

3010838917

Entity Name

AirLife Finland Oy

City/State/Country

Helsinki Uusimaa, FI

Establishment Address

Kuortaneenkatu 2, Helsinki Uusimaa FIN-00510, FI

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SunMed Group Holdings, LLC dba AirLife (Owner Number: 10044795)

Owner / Operator Contact Address

2710 Northridge Drive NW, Suite A, Grand Rapids, MI 49544, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043572

PMA Number

N/A

All Registered Proprietary Names

CABLE, ELECTRODE BEDDING, DISPOSABLE, MEDICAL HMEF Mini/s CABLE, TRANSDUCER AND ELECTRODE, PATIENT Thermometer, electronic HMEF 750, M1038639, M1010538, M1005260, M1004132 BreathTech HME Medline HME Ventlab HME CONDENSER, HEAT AND MOISTURE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Circuits Heated Wire Resuscitation Bags Flow-Inflating Anesthesia breathing circuit kit (adult & pediatric) Circuits Anesthesia O2 Delivery Adapters And Connectors Nebulizers Large Volume Prefilled And Dry Westmed Breathing Circuits Humidifiers Heated CONNECTOR, AIRWAY RECORDER, PAPER CHART Adhesive Tape and Bandage M1003346 Uni-Filter Junior, M1003345 Uni-Filter Mini, 557022500 Uni-Filter/S, 557021200 U-Filters Filters, M1010541 Angled Uni-Filters/S 8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000 CATHETER, UPPER URINARY TRACT CABLE, TRANSDUCER AND ELECTRODE, PATIENT Airlife Infant Skin Temp Probe Medisorb Multi-Absorber Original, Disposable ABSORBENT, CARBON-DIOXIDE Medisorb EX, Disposable Blood Pressure Cuff CABLE, TRANSDUCER AND ELECTRODE, PATIENT Electrode Oximeter CABLE, TRANSDUCER AND ELECTRODE, PATIENT CABLE, TRANSDUCER AND ELECTRODE, PATIENT HMEF 1000, M1038637, M1010534, 8570230, 8570203, 557085500, 557071600, 557071500, 557050200 (EOL), 557019500 CABLE, TRANSDUCER AND ELECTRODE, PATIENT TRANSDUCER, GAS PRESSURE Electrode, electrocardiograph Reservoir Bag CABLE, TRANSDUCER AND ELECTRODE, PATIENT Vent Mask II Breath Tech Mask Soft-Aire Mask Vent Mask Westmed Anesthesia Masks MASK, GAS, ANESTHETIC CABLE, TRANSDUCER AND ELECTRODE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2023-07-18
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-07-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-02-28
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-07-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-01-23
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2018-01-17
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-07-18
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2023-07-20
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2018-04-05
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2023-07-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-01-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-01-23
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2023-07-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2024-07-22
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2023-07-18
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2013-07-29
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2023-07-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-07-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-01-23
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18
BXO	Transducer, Gas Pressure	Anesthesiology	Class 1	868.2900	2023-07-18
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2023-07-18
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2018-04-09
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-01-17
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-07-18

Official Correspondent

Rob Yamashita

US Agent Details

Rob Yamashita Business: AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

SunMed Group Holdings, LLC dba AirLife

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010362947	Shenzhen Vital Signs-KTL Medical Instrument Co Ltd	Shenzhen Guangdong, CN
3030308442	SUNMED GROUP HOLDINGS, LLC dba AirLife	Litchfield Park, AZ, US
8030647	Westmed de Mexico, S.A de C.V	MAGDALENA Sonora, MX
3006606984	Westmed de Mexico, S.A de C.V	NOGALES Sonora, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K880323	Medtronic Vascular	MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR	1988-03-22
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18

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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3033919280	DONGGUAN GOOCHAIN TECHNOLOGY CO., LTD	Dongguan Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010838917. Last updated year: 2026. Please use registration number 3010838917 when referencing this establishment in official correspondence.