FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-Medicus™
DI: 20763000115993
·
Model: 96552
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Bio-Medicus™
- Primary DI
- 20763000115993
- Version / Model
- 96552
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-10-24
- Public Version
- 3
- Public Version Date
- 2023-10-03
- Public Version Status
- Update
- Public Device Record Key
- 2f35f4ed-9477-4709-af48-e8b0cc28e4e3
Device Description
KIT 96552 BIO-MEDICUS INSERTION ART
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 | 20763000115993 | GS1 | ||||
| Unit of Use | 00763000115999 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 x 8 Fr/10 Fr, 1 x 12 Fr/14 Fr, 1 x 16 Fr/18 Fr | ||
| Guidewire Length | 100.0 | Centimeter | |
| Guidewire Diameter | 0.965 | Millimeter | |
| Needle Gauge | 18.0 | Gauge |