FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gundry®
DI: 20643169454297
·
Model: 94115T
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Gundry®
- Primary DI
- 20643169454297
- Version / Model
- 94115T
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-05-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 34dc8005-88f4-4139-9d6b-aafb49b049b9
- Distribution End Date
- 2017-08-25
Device Description
CANNULA 94115T RCSP 15F SIL-MAN 10P 17L
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 |
|---|---|---|---|---|
| 36109 | Coronary sinus cannula | A sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into the ostium of the coronary sinus to provide retrograde coronary perfusion/cardioplegia during cardiopulmonary bypass or minimally invasive surgery. It may be equipped with a self-inflating low pressure balloon that is typically used for back flushing the coronary vessel in the event of inadvertent coronary air embolization. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20643169454297 | GS1 | ||||
| Unit of Use | 00643169454293 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K860149 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 15.0 | French |