FDA UDI
In Commercial Distribution
🇺🇸 United States
3/16'' x 3/16'' Straight Connector
DI: 36641670004476
·
Model: 1.7
·
Cardiomed Supplies Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- 3/16'' x 3/16'' Straight Connector
- Primary DI
- 36641670004476
- Version / Model
- 1.7
- Catalog Number
- C-675
- Company Name
- Cardiomed Supplies Inc
- Labeler DUNS
- 240623124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-12-02
- Public Version
- 1
- Public Version Date
- 2020-12-10
- Public Version Status
- New
- Public Device Record Key
- 379a782f-88f3-4ccb-83e0-c82748c5094b
Device Description
This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.
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
- Yes
- 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 |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63417 | Low-pressure tubing connector, single-use, sterile | A sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 16641670004465 | GS1 | ||||
| Primary | 36641670004476 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K833112 | 000 |