Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006240053

FEI Number

3006240053

Entity Name

Creative Foam Corporation dba MT. OLIVE MFG

City/State/Country

Mooresville, IN, US

Establishment Address

3304 Hancel Cir, Mooresville, IN 46158, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Mt. Olive Mfg., Co. (Owner Number: 10051845)

Owner / Operator Contact Address

3304 Hancel Circle, Mooresville, IN 46158, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trilogy 100 SimplyGo CoughAssist Trilogy 202 Scott Foot Care

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2026-01-09
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2026-01-09
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-10-12
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-10-12
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-10-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-10-12
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-10-12
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2026-01-09
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2016-05-10
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2016-05-10
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2026-01-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2023-08-30

Official Correspondent

Danielle Larimer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mt. Olive Mfg., Co.

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
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Similar Registrations

Registration Number	Establishment Name	Location
3029922922	ORIGIN MEDICAL DEVICES HUNGARY KFT	Vac Pest, HU
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
2024500	COVIDIEN	CARLSBAD, CA, US
3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006240053. Last updated year: 2026. Please use registration number 3006240053 when referencing this establishment in official correspondence.