Hemagard HGKAX0808
GUDID 00384401015109
Hemagard Knitted Axillo-bifemoral Collagen Coated Vascular Graft
INTERVASCULAR SAS
Synthetic vascular graft| Primary Device ID | 00384401015109 |
| NIH Device Record Key | e433bd35-6fd5-4952-8e22-357e9568b33f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemagard |
| Version Model Number | HGKAX0808 |
| Catalog Number | HGKAX0808 |
| Company DUNS | 382174019 |
| Company Name | INTERVASCULAR SAS |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Length | 100 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384401015109 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964625
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [Hemagard]
| 00384401015314 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401015109 | Hemagard Knitted Axillo-bifemoral Collagen Coated Vascular Graft |
| 00384401015093 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401015086 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401015079 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401015062 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401015055 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401015048 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401015031 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401015017 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401014812 | Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft |
| 00384401014805 | Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401014799 | Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401014782 | Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401014775 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014768 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014751 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014744 | Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401014737 | Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401014720 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014713 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014706 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014690 | Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401014683 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014676 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014669 | Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401014478 | Hemagard Knitted Axillo-bifemoral Collagen Coated Vascular Graft |
| 00384401014461 | Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft |
| 00384401014454 | Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft |
| 00384401014447 | Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft |
| 00384401014430 | Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft |
| 00384401014423 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401014416 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401014409 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401014393 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401014386 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401014379 | Hemagard Knitted Bifurcated Collagen Coated Vascular Graft |
| 00384401014362 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014355 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014348 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014331 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014324 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014317 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014300 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014294 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014287 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014270 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014263 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014256 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
| 00384401014249 | Hemagard Knitted Straight Collagen Coated Vascular Graft |
Trademark Results [Hemagard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMAGARD 85288714 4254635 Live/Registered |
Maquet Cardiovascular LLC 2011-04-07 |
 HEMAGARD 73825384 not registered Dead/Abandoned |
HEMACARE CORPORATION 1989-09-14 |
 HEMAGARD 72436945 0992604 Dead/Expired |
CLIPP, WENDELL V. 1972-09-28 |
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