MAXIFLO™ W30ST0406
GUDID 05037881010106
MAXIFLO ePTFE Vascular Prosthesis Stepped Taper with Wrap
VASCUTEK LTD
Synthetic vascular graft| Primary Device ID | 05037881010106 |
| NIH Device Record Key | 86c41d12-10f3-4e9f-99d9-3063670152bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAXIFLO™ |
| Version Model Number | W30ST0406 |
| Catalog Number | W30ST0406 |
| Company DUNS | 229053087 |
| Company Name | VASCUTEK LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
| Length | 30 Centimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F). |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05037881010106 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092863
FDA Product Code
| DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-24 |
| Device Publish Date | 2015-09-23 |
On-Brand Devices [MAXIFLO™]
| 05037881152349 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152332 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152325 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152318 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152301 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152295 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152288 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152271 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152264 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152257 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152240 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152233 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152226 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152219 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152202 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152196 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152189 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152172 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152165 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152158 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152141 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152134 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152127 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152110 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152097 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152080 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152073 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152066 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152042 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152035 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152028 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881152011 | ePTFE ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE SUPPORT |
| 05037881151991 | MAXIFLO ePTFE Vascular Prosthesis |
| 05037881151984 | MAXIFLO ePTFE Vascular Prosthesis Wrap with Unity Construction ULTRATHIN WALL STRAIGHT WRAPPED, |
| 05037881151977 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151960 | MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151946 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151939 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151922 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151915 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151892 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151885 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151878 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151861 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151847 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151830 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151823 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151816 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151809 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
| 05037881151793 | MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE |
Trademark Results [MAXIFLO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAXIFLO 90009006 not registered Live/Pending |
AIREAU QUALITÃ CONTRÃLE INC. 2020-06-18 |
 MAXIFLO 78075914 not registered Dead/Abandoned |
Maxiflo 2001-07-26 |
 MAXIFLO 77377686 3578897 Dead/Cancelled |
RBH/MILL & ELEVATOR SUPPLY, INC. 2008-01-22 |
 MAXIFLO 74559161 1994003 Live/Registered |
COVIDIEN LP 1994-08-10 |
 MAXIFLO 73392789 not registered Dead/Abandoned |
AQUALITY, INC. 1982-09-29 |
 MAXIFLO 72018422 0645105 Dead/Expired |
ENGINE LIFE PRODUCTS CORPORATION 1956-10-30 |
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