FDA UDI
In Commercial Distribution
🇺🇸 United States
Maquet HL-20 System
DI: 04037691224510
·
Model: AEP 20-415 Bubble Level Monitoring Kit
·
Maquet Cardiopulmonary AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Maquet HL-20 System
- Primary DI
- 04037691224510
- Version / Model
- AEP 20-415 Bubble Level Monitoring Kit
- Catalog Number
- 70101.0853
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3167bc60-6953-4899-a3ea-09d9db6f970d
Device Description
Air Embolism Protection (AEP) System including a bubble/level monitoring kit. This AEP is an accessory for The Heart-Lung Machine HL 20 , which is a modular system for regulation, control and monitoring of the extracorporeal circulation. Its purpose is the support and maintenance of the extracorporeal blood circulation and is used during cardiac surgeries.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | Cardiovascular | 870.4220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35440 | Cardiopulmonary bypass system air bubble/fluid level detector | A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04037691224510 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K943803 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 28.215 | Liter | |
| Weight | 4220 | Gram |