FDA UDI
In Commercial Distribution
🇺🇸 United States
CORODYN
DI: 04046955651979
·
Model: 601266-02
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- CORODYN
- Primary DI
- 04046955651979
- Version / Model
- 601266-02
- Catalog Number
- 601266-02
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-08-17
- Public Version
- 2
- Public Version Date
- 2023-09-06
- Public Version Status
- Update
- Public Device Record Key
- 51e6b49a-8832-409d-ae50-f07cf70fe468
Device Description
CORODYN P1 F6 60CM WEDGE PRESS BALLOON
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYG | CATHETER, FLOW DIRECTED | Cardiovascular | 870.1240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43077 | Coronary sinus venogram catheter | A flexible tube designed for use within the coronary sinus to infuse contrast medium solution into the coronary vasculature for venogram imaging procedures. It typically consists of a double-lumen tube, one lumen for the inflation of a balloon at the distal tip and the other for the infusion of the contrast solution. It has a Luer-lock connector to connect to the solution injection device, and a stopcock to close the infusion lumen to prevent backflow. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04046955651962 | GS1 | ||||
| Primary | 04046955651979 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A DRY PLACE