Hemolung® CR4 Controller

Basic Information

• Brand Name: Hemolung® CR4 Controller
• Primary DI: 00850046004056
• Version / Model: 21000
• Company Name: Alung Technologies, Inc.
• Labeler DUNS: 129408592
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-21
• Public Version: 1
• Public Version Date: 2023-03-01
• Public Version Status: New
• Public Device Record Key: 044baf19-dc8b-498b-b426-0f6bb6acb11a

Device Description

Hemolung® CR4 Controller

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QOH	Extracorporeal System For Carbon Dioxide Removal	Cardiovascular	870.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58723	Mobile extracorporeal gas exchange system	An assembly of devices designed to provide partial extracorporeal respiratory support to treat acute hypercapnic respiratory failure in settings where the patient may be moved while on therapy [e.g., intensive care unit (ICU), emergency room]. It is intended to function by pumping the patient?s blood through a hollow-fibre membrane gas exchanger so that carbon dioxide is removed and oxygen added, and returning the blood to the patient?s venous system (veno-venous), typically as an alternative to mechanical ventilation. It consists of a control unit, a single-use cartridge pump, and a single-use catheter kit. The system is not intended for long-term use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850046004056	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN210006	000