| Primary Device ID | 57460691959496 |
| NIH Device Record Key | b2c8bea5-e334-4adb-8478-c8e88514472d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM) |
| Version Model Number | T100671M |
| Catalog Number | T100671M |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07460691959491 [Primary] |
| GS1 | 57460691959496 [Package] Contains: 07460691959491 Package: Shipper [10 Units] In Commercial Distribution |
| KRA | Catheter, Continuous Flush |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2020-04-24 |