FDA UDI
In Commercial Distribution
🇺🇸 United States
MAQUET CARDIOHELP
DI: 04037691651873
·
Model: FBS 3/8" x 3/32" L0.9
·
Maquet Cardiopulmonary AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAQUET CARDIOHELP
- Primary DI
- 04037691651873
- Version / Model
- FBS 3/8" x 3/32" L0.9
- Catalog Number
- 70104.8001
- 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
- 96e1f1ed-c828-4e00-ae9d-86e5caed8dcf
Device Description
Flow-/bubble sensor for 3/8“ x 3/32“ tubing, length 0.9 m. This bubble sensor is an accessory for CARDIOHELP System as a miniaturized and light medical perfusion system. The general function of the CARDIOHELP System is to drive, to control, to monitor and to protocol the extra corporeal circulation (ECC). The CARDIOHELP System acts as a drive unit for a disposable tubing set including at least pump and oxygenator. This system is designed for inter- and intra-hospital transportation (transportation (limitations may apply for individual disposables).
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 | 04037691651873 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102726 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1.274 | Liter | |
| Weight | 0.172 | Kilogram |