FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-Medicus™
DI: 00763000193379
·
Model: CB96570-019
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bio-Medicus™
- Primary DI
- 00763000193379
- Version / Model
- CB96570-019
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-21
- Public Version
- 2
- Public Version Date
- 2022-09-22
- Public Version Status
- Update
- Public Device Record Key
- bbf1e185-f489-4212-9e43-fa069c83a5f6
Device Description
CANN CB96570-019 BIO-MEDICUS 19FR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34893 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial | A semi-rigid or rigid tube intended to be surgically inserted into an artery to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000193379 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142673 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 18.0 | Centimeter | |
| Catheter Gauge | 19.0 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the product at room temperature.
- Type
- Handling Environment Temperature
- Temperature Range
- – 40 Degrees Celsius