FDA UDI
In Commercial Distribution
🇺🇸 United States
PEAK MEDICAL
DI: G4532450375M0
·
Model: 24-50375M
·
Peak Medical Distribution Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PEAK MEDICAL
- Primary DI
- G4532450375M0
- Version / Model
- 24-50375M
- Company Name
- Peak Medical Distribution Inc.
- Labeler DUNS
- 078393632
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-31
- Public Version
- 1
- Public Version Date
- 2023-06-08
- Public Version Status
- New
- Public Device Record Key
- f7899bed-29d1-436e-ba78-90aba2b5d4a0
Device Description
Re-usable - medium - 45 degree Angle Shaft with 3.75mm tip Re-usable Stanless Steel Coronary Perfusion Cannula. 24cm overall length, 3mm suction tube O.D.; 2mm I.D. Tip with 4 holes. Female Luer Lock.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
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 | G4532450375M0 | HIBCC |