VAMP Jr VJ0095
GUDID 50690103199661
Blood Management System
Edwards Lifesciences LLC
Arterial blood sampling kit Arterial blood sampling kit| Primary Device ID | 50690103199661 |
| NIH Device Record Key | 917693fc-d785-4713-aaf2-6fe260b15d9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VAMP Jr |
| Version Model Number | VJ0095 |
| Catalog Number | VJ0095 |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 26 Inch |
| Length | 26 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103199666 [Primary] |
| GS1 | 50690103199661 [Package] Contains: 00690103199666 Package: Shipper [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K896819
FDA Product Code
| KRA | Catheter, Continuous Flush |
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 | 2017-12-12 |
Devices Manufactured by Edwards Lifesciences LLC
| 00690103217124 - HemoSphere Vita | 2024-03-05 PRESSURE CONTROLLER KIT |
| 00690103218848 - HemoSphere Vita | 2024-03-05 VitaWave Module |
| 00690103218855 - HemoSphere Vita | 2024-03-05 HemoSphere Vita Monitor |
| 00690103218862 - HemoSphere Vita | 2024-03-05 Vita Technology Module |
| 50690103218898 - VitaWave | 2024-02-28 VitaWave Finger Cuff Adult |
| 00690103217483 - EVOQUE | 2024-02-15 Edwards EVOQUE Stabilizer Plate |
| 00690103217490 - EVOQUE | 2024-02-15 Edwards EVOQUE Loading System |
| 00690103217506 - EVOQUE | 2024-02-15 Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators) |
Trademark Results [VAMP Jr]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAMP JR 76407942 2688567 Live/Registered |
Edwards Lifesciences Corporation 2002-05-14 |
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