FDA UDI
In Commercial Distribution
🇺🇸 United States
ROTAFLOW
DI: 04037691650326
·
Model: Centrifugal Pump, SOFTLINE
·
Maquet Cardiopulmonary AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ROTAFLOW
- Primary DI
- 04037691650326
- Version / Model
- Centrifugal Pump, SOFTLINE
- Catalog Number
- 70104.7553
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-30
- Public Version
- 4
- Public Version Date
- 2020-05-19
- Public Version Status
- Update
- Public Device Record Key
- 5bd5800b-b14d-4d03-bb8a-305256fb23ee
Device Description
BO-RF-32-USA#RotaFlow Centrifugal Pump with SOFTLINE Coating
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KFM | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | Cardiovascular | 870.4360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31718 | Cardiopulmonary bypass system centrifugal pump | A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04037691650333 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04037691650326 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090515 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | connection size 3/8 Inch |