| Primary Device ID | 10876604004761 |
| NIH Device Record Key | fb1ea832-5bea-4a5f-9863-b61d39770c60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synergy-XS |
| Version Model Number | A14-04260-IR-03 |
| Catalog Number | A14-04260-IR |
| Company DUNS | 806251398 |
| Company Name | Health Line International Corporation |
| Device Count | 1 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00876604004764 [Primary] |
| GS1 | 10876604004761 [Package] Contains: 00876604004764 Package: Inner [5 Units] In Commercial Distribution |
| GS1 | 20876604004768 [Package] Package: Carton [4 Units] In Commercial Distribution |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-01 |
| Device Publish Date | 2023-05-24 |
| 10876604004761 | 4F x 60 cm Dual Lumen Synergy-XS CT PICC IR Kit |
| 10876604004747 | 3F x 60 cm Single Lumen Synergy-XS CT PICC IR Kit |
| 10876604004686 | 4F x 60 cm Dual Lumen Synergy-XS CT PICC Nursing Kit |
| 10876604004679 | 3F x 60 cm Single Lumen Synergy-XS CT PICC Nursing Kit |
| 10876604004624 | 4F x 60 cm Dual Lumen Synergy-XS CT PICC Basic Kit |
| 10876604004600 | 3Fr x 60cm Single Lumen Synergy-XS CT PICC Basic Kit |