FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MAXIFLO™
DI: 05037881151663
·
Model: S3006P
·
VASCUTEK LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MAXIFLO™
- Primary DI
- 05037881151663
- Version / Model
- S3006P
- Catalog Number
- S3006P
- Company Name
- VASCUTEK LTD
- Labeler DUNS
- 229053087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-19
- Public Version
- 9
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- 292debda-7b09-41b5-8c4e-39429203bfc4
- Distribution End Date
- 2019-03-30
Device Description
MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE SUPPORT Wrap
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 |
|---|---|---|---|---|
| DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | Cardiovascular | 870.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35281 | Synthetic vascular graft, non-medicated | An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05037881151663 | GS1 |
Customer Contacts
- Phone
- +1(800)888-3786
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 6 | Millimeter | |
| Length | 30 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).