Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007709321

FEI Number

3007709321

Entity Name

EXCELERON MEDICAL, LLC

City/State/Country

Saint Paul, MN, US

Establishment Address

5000 Township Pkwy, Saint Paul, MN 55110, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Exceleron Medical (Owner Number: 10038616)

Owner / Operator Contact Address

6 Apple Orchard Court, Dellwood, MN 55110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2020-12-03
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2012-06-14

Official Correspondent

Keith Roberts

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exceleron Medical

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
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Similar Registrations

Registration Number	Establishment Name	Location
3007337939	FLODINS FILTER AB	Lysekil Vastra Gotaland, SE
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3007289408	Medline Canada	Guelph Ontario, CA
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007709321. Last updated year: 2026. Please use registration number 3007709321 when referencing this establishment in official correspondence.