FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04037691583280
·
Model: TOP SHELF FOR ROTAFLOW CONSOLE
·
Maquet Cardiopulmonary AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 04037691583280
- Version / Model
- TOP SHELF FOR ROTAFLOW CONSOLE
- Catalog Number
- 70104.7815
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-19
- Public Version
- 3
- Public Version Date
- 2018-04-25
- Public Version Status
- Update
- Public Device Record Key
- 1585416b-ff58-466a-bf2d-a8f6b0ea98d0
Device Description
TOP SHELF KIT FOR ROTAFLOW CONSOLE (SPRINTER CART)
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40596 | Electromechanical device/system transport trolley | A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04037691583280 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]