ICU Medical, Inc.

FDA Device Registration & Listing · Olive Branch, MS, US · Registration 3008818980

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008818980
FEI Number
3008818980
Entity Name
ICU Medical, Inc.
City/State/Country
Olive Branch, MS, US
Establishment Address
9124 Polk Lane, Suite 101, Olive Branch, MS 38654, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ICU Medical, Inc. (Owner Number: 8020727)
Owner / Operator Contact Address
951 Calle Amanecer, San Clemente, CA 92673, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

PEDIPLUS MANUAL RESUSCITATOR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2007-12-04

Official Correspondent

Michelle Doherty

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ICU Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004187702 ICU Medical (SM Prodotti) Italia S.r.L. Latina Scalo - LT, IT
3011237704 ICU Medical Czech Republic a. s. Hranice Olomoucky Kraj, CZ
1824231 ICU Medical, Inc. Gary, IN, US
1526863 ICU Medical, Inc. DUBLIN, OH, US
3012307300 ICU Medical, Inc. Minneapolis, MN, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2010 Unomedical 2
Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010 Unomedical 2
Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008818980. Last updated year: 2026. Please use registration number 3008818980 when referencing this establishment in official correspondence.
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