Elite HV® 612805
GUDID 04046964347566
7FR X 7CM X 021 HEMO INTRODUCER SET
B BRAUN INTERVENTIONAL SYSTEMS, INC
Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable| Primary Device ID | 04046964347566 |
| NIH Device Record Key | 4d1b0612-0731-4aba-89e0-69f8c0e24d17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elite HV® |
| Version Model Number | 612805 |
| Catalog Number | 612805 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, INC |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964347542 [Unit of Use] |
| GS1 | 04046964347566 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043525
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2019-06-07 |
| Device Publish Date | 2016-08-09 |
On-Brand Devices [Elite HV®]
| 04046964348822 | 3FR X 7CM X 018PT HEMO INTRODUCER SET |
| 04046964348785 | 7FR X 24CM HEMO PT INTRODUCER W/O 038 |
| 04046964348747 | 6FR X 24CM HEMO PT INTRODUCER W/O 038 |
| 04046964348709 | INTRO KIT HEMO PT 7F X 12CM W 0.038 GW |
| 04046964348662 | 6FR X 12CM X .038 HEMO PT INTRODUCER SET |
| 04046964348624 | 5FR X 12CM X .038 HEMO PT INTRODUCER SET |
| 04046964348587 | 7FR X 7CM X 021 HEMO PT INTRODUCER SET |
| 04046964348532 | 6FR X 7CM X 021 HEMO PT INTRODUCER SET |
| 04046964348495 | 5FR X 7CM X 021 HEMO PT INTRODUCER SET |
| 04046964347962 | 9FRX 24CM ARTERIAL HEMO INTRO W/O.038 GW |
| 04046964347924 | 8FRX 24CM ARTERIAL HEMO INTRO W/O.038 GW |
| 04046964347887 | 7FRX24CM ARTERIAL HEMO INTRO W/O .038 GW |
| 04046964347849 | 6FR X 24CM ARTERIAL HEMO INTRO W/038 GW |
| 04046964347801 | 9FR X 12CM ARTERIAL HEMO INTRO W/038 GW |
| 04046964347764 | 8FR X 12CM ARTERIAL HEMO INTRO W/038 GW |
| 04046964347726 | 7FR X 12CM ARTERIAL HEMO INTRO W/038 GW |
| 04046964347689 | 6FR X 12CM ARTERIAL HEMO INTRO W/038 GW |
| 04046964347641 | 5FR X 12CM ARTERIAL HEMO INTRO W/038 GW |
| 04046964347597 | 4FR X 12CM X 035 HEMO INTRODUCER SET |
| 04046964347566 | 7FR X 7CM X 021 HEMO INTRODUCER SET |
| 04046964347528 | 6FR X 7CM X 021 HEMO INTRODUCER SET |
| 04046964347474 | 5FR X 7CM X 021 HEMO INTRODUCER SET |
| 04046964347436 | 4FR X 7CM X 021 HEMO INTRODUCER SET |
| 04046964347399 | 3FR X 7CM X 021 HEMO INTRODUCER SET |
| 04046964347351 | 3FR X 7CM X 018 AU HEMO INTRODUCER SET |
Trademark Results [Elite HV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELITE HV 78691289 3120596 Live/Registered |
Galt Medical Corporation 2005-08-12 |
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