Hemolung® CR4 Controller

Primary DI
00850046004056
Brand
Hemolung® CR4 Controller
Company
Alung Technologies, Inc.
Model
21000
Device description
Hemolung® CR4 Controller
Published
2023-02-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QOHExtracorporeal System For Carbon Dioxide Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOHExtracorporeal System For Carbon Dioxide RemovalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210006000Hemolung Respiratory Assist SystemAlung Technologies, Inc.2021-11-13QOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850046004056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046004056008500460040568500460040560850046004056

GMDN Terms#

Term, Definition table
TermDefinition
Mobile extracorporeal gas exchange systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(412) 697-3370tl.regulatory@livanova.com

Regulatory Flags#

DUNS number
129408592
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046004223Hemolung® Cartridge Kit401002023-02-21
00850046004230Hemolung® Accessories Kit402002023-02-21
00850046004247Hemolung® Rinse Back Kit403002023-02-21
00850046004254Hemolung® Cartridge with Blood Tubing404002023-02-21
00850046004278Hemolung® 15.5 Fr Femoral Catheter Kit406002023-02-21
00850046004308Hemolung® 15.5 Fr Jugular Catheter Kit409002023-02-21
00850046004322Hemolung® Catheter Spare Parts Kit411002023-02-21
00850046004476Hemolung® Cartridge Spare Parts Kit412002023-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850046004223Hemolung® Cartridge KitAlung Technologies, Inc.QOH2023-02-21
00850046004230Hemolung® Accessories KitAlung Technologies, Inc.QOH2023-02-21
00850046004247Hemolung® Rinse Back KitAlung Technologies, Inc.QOH2023-02-21
00850046004254Hemolung® Cartridge with Blood TubingAlung Technologies, Inc.QOH2023-02-21
00850046004278Hemolung® 15.5 Fr Femoral Catheter KitAlung Technologies, Inc.QOH2023-02-21
00850046004308Hemolung® 15.5 Fr Jugular Catheter KitAlung Technologies, Inc.QOH2023-02-21
00850046004322Hemolung® Catheter Spare Parts KitAlung Technologies, Inc.QOH2023-02-21
00850046004476Hemolung® Cartridge Spare Parts KitAlung Technologies, Inc.QOH2023-02-21