Elite HV® 612810
GUDID 04046964347764
8FR X 12CM ARTERIAL HEMO INTRO W/038 GW
B BRAUN INTERVENTIONAL SYSTEMS, INC
Vascular catheter introduction set, nonimplantable| Primary Device ID | 04046964347764 |
| NIH Device Record Key | 3ff26dd2-5d65-4a5e-b26a-2b547a66acef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elite HV® |
| Version Model Number | 612810 |
| Catalog Number | 612810 |
| 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 | 04046964347740 [Unit of Use] |
| GS1 | 04046964347764 [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 | 4 |
| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.