MAXIFLO™ S1005
GUDID 05037881002644
MAXIFLO ePTFE Vascular Prosthesis Standard Wall Wrap
VASCUTEK LTD
Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft| Primary Device ID | 05037881002644 |
| NIH Device Record Key | ceb4aab4-b886-4185-a871-6c03ff78c00f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAXIFLO™ |
| Version Model Number | S1005 |
| Catalog Number | S1005 |
| 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
| Lumen/Inner Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 10 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05037881002644 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041528
FDA Product Code
| DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| DYF | PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM 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 | 4 |
| Public Version Date | 2020-03-25 |
| Device Publish Date | 2015-10-19 |
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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