AccessGUDID - DEVICE: Hemolung® Cartridge Spare Parts Kit (00850046004476)

GUDID

Device Identifier (DI) Information

Brand Name: Hemolung® Cartridge Spare Parts Kit
Version or Model: 41200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alung Technologies, Inc.

Primary DI Number: 00850046004476
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 129408592 *Terms of Use

Device Description: Hemolung® Cartridge Spare Parts Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QOH	Extracorporeal System For Carbon Dioxide Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210006	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 38e75543-8a9e-421e-b220-ce7936b7d7fa
Public Version Date: August 13, 2024
Public Version Number: 2
DI Record Publish Date: February 21, 2023