Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1625392

FEI Number

1000058335

Entity Name

INTERNATIONAL BIOMEDICAL, LTD.

City/State/Country

AUSTIN, TX, US

Establishment Address

8206 Cross Park Dr, AUSTIN, TX 78754, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INTERNATIONAL BIOMEDICAL, LTD. (Owner Number: 1629497)

Owner / Operator Contact Address

8206 CROSS PARK DR., P.O. BOX 143449, Austin, TX 78754, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K870173

PMA Number

N/A

All Registered Proprietary Names

Puffin Infant Resuscitator LifeBorne Infant Resuscitator NxtGen Infant Transport Incubator InfaTherm Infant Warming Mattress Glucose Monitor Wee Sight Transilluminator WeeSpecs Supreme WeeSpecs Airborne Phototherapy Light Bar Voyager with Optional PulseOx Transport Incubator Aviator with Optional PulseOx Transport Incubator Voyager Transport Incubator LC Accu-Bar Temp Trend Indicator Aeronox Nitric Oxide Delivery System Blood Gas Monitor ECG Patient Cable Puffin Lite Infant Resuscitator AIRBORNE 750I INFANT Aviator Transport Incubator Aeronox Squishon Mattress Squishon 2, Gel Pillow Gel-E Donut, Extra Small Squishon 3, Gel Pillow Gel-E Donut, Small Gel_E Donut, Medium NeoPod T Transport Humidifier

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2014-12-30
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2022-07-19
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2022-11-21
LZF	Pump, Infusion, Analytical Sampling	General Hospital	Class 2	880.5725	2008-01-11
HJN	Transilluminator, Battery-Powered	Ophthalmic	Class 1	886.1945	2021-07-09
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2021-07-09
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2016-09-22
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2012-01-03
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2012-01-03
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2013-06-28
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2021-07-09
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2013-06-28
LZF	Pump, Infusion, Analytical Sampling	General Hospital	Class 2	880.5725	2008-01-11
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2020-06-05
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2019-02-21
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	1992-12-03
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2013-06-28
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2008-01-02
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2008-01-02
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2008-01-02
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2008-01-02
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-07-09
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2023-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTERNATIONAL BIOMEDICAL, LTD.

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
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0028-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0029-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Similar Registrations

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1924066	Allied Medical LLC	Earth City, MO, US
8044169	PLAXTRON INDUSTRIAL (M) SDN. BHD.	IPOH Perak, MY
9610861	O-TWO MEDICAL TECHNOLOGIES, INC.	Brampton Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1625392. Last updated year: 2026. Please use registration number 1625392 when referencing this establishment in official correspondence.