ANGIO-SEAL C610134
GUDID 30389701011784
ANGIO-SEAL EVOLUTION Vascular Closure Device
TERUMO MEDICAL CORPORATION
Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen| Primary Device ID | 30389701011784 |
| NIH Device Record Key | e6d7c259-6211-4674-8db6-9254571bcadb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANGIO-SEAL |
| Version Model Number | C610134 |
| Catalog Number | C610134 |
| Company DUNS | 962520628 |
| Company Name | TERUMO MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00389701011783 [Primary] |
| GS1 | 30389701011784 [Package] Contains: 00389701011783 Package: Shelfbox [5 Units] In Commercial Distribution |
| GS1 | 50389701011788 [Package] Package: Carton [2 Units] In Commercial Distribution |
FDA Product Code
| MGB | Device, hemostasis, vascular |
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 | 2018-10-22 |
| Device Publish Date | 2017-04-20 |
On-Brand Devices [ANGIO-SEAL]
| 30389701011869 | ANGIO-SEAL STS Plus Vascular Closure Device |
| 50389701011856 | ANGIO-SEAL STS Plus Vascular Closure Device |
| 50389701011825 | ANGIO-SEAL VIP Vascular Closure Device |
| 50389701011818 | ANGIO-SEAL VIP Vascular Closure Device |
| 30389701011784 | ANGIO-SEAL EVOLUTION Vascular Closure Device |
| 50389701011771 | ANGIO-SEAL EVOLUTION Vascular Closure Device |
Trademark Results [ANGIO-SEAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIO-SEAL 88050352 5696539 Live/Registered |
Terumo Puerto Rico, L.L.C. 2018-07-24 |
 ANGIO-SEAL 75005288 2118314 Dead/Cancelled |
QUINTON INSTRUMENT COMPANY 1995-10-13 |
 ANGIO-SEAL 74666330 2154010 Live/Registered |
TERUMO PUERTO RICO L.L.C. 1995-04-27 |
 ANGIO-SEAL 74344004 not registered Dead/Abandoned |
QUINTON INSTRUMENT COMPANY 1992-12-23 |
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