FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cannula Graft™
DI: 05037881009537
·
Model: CGS2008S
·
VASCUTEK LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cannula Graft™
- Primary DI
- 05037881009537
- Version / Model
- CGS2008S
- Catalog Number
- CGS2008S
- Company Name
- VASCUTEK LTD
- Labeler DUNS
- 229053087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 6
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 53deba1a-0629-472d-aafd-178f8ffda085
- Distribution End Date
- 2018-08-13
Device Description
Cannula Graft PVC Cannula with Gelatin Sealed ePTFE Vascular Prosthesis
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 05037881009537 | GS1 |
Customer Contacts
- Phone
- +1(800)888-3786
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 8 | Millimeter | |
| Device Size Text, specify | Graft Length 20cm | ||
| Length | 50 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.