FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Intersept™
DI: 00763000219123
·
Model: CB2994
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Intersept™
- Primary DI
- 00763000219123
- Version / Model
- CB2994
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-01
- Public Version
- 3
- Public Version Date
- 2023-08-08
- Public Version Status
- Update
- Public Device Record Key
- 614e8e12-e0fa-454f-be32-05b4a19de13b
- Distribution End Date
- 2020-03-04
Device Description
TUB CB2994 STER 72IN 3/8X3/32 5PK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35441 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20763000219127 | GS1 | PK | 5 | Not in Commercial Distribution | 2020-03-04 |
| Primary | 00763000219123 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171979 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2.4 mm Wall Thickness | ||
| Length | 1.8 | Meter | |
| Lumen/Inner Diameter | 9.5 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the product at room temperature.