NA
- Primary DI
- 00199150082902
- Brand
- NA
- Company
- MEDTRONIC, INC.
- Model
- BB12W52R
- Device description
- CUSTOM PACK BB12W52R EVL
- Published
- 2026-05-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K171979 | 000 | Tubing Pack | Medtronic, Inc. | 2017-10-27 | DWF |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00199150082902 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00199150082902 | 00199150082902 | 199150082902 | 0199150082902 |
GMDN Terms
| Term | Definition |
|---|
| Cardiopulmonary bypass system blood tubing set | A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 | 0 | |
Regulatory Flags
- DUNS number
- 006261481
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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