FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hemolung® Cartridge Kit
DI: 00850046004223
·
Model: 40100
·
Alung Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hemolung® Cartridge Kit
- Primary DI
- 00850046004223
- Version / Model
- 40100
- Company Name
- Alung Technologies, Inc.
- Labeler DUNS
- 129408592
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-21
- Public Version
- 2
- Public Version Date
- 2024-08-13
- Public Version Status
- Update
- Public Device Record Key
- be7b40fd-be9a-4321-b0e1-56719f5279bc
- Distribution End Date
- 2024-03-31
Device Description
Hemolung® Cartridge Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 00850046004223 | GS1 |
Customer Contacts
- Phone
- (412) 697-3370
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210006 | 000 |