| Primary Device ID | 20876604001705 |
| NIH Device Record Key | 35be2b53-c1d9-4436-b38e-9f4bb7d1b18b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Extension Set |
| Version Model Number | HLEV23554 |
| 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 | true |
| 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 | 00876604001701 [Primary] |
| GS1 | 10876604001708 [Package] Contains: 00876604001701 Package: Inner Pack [50 Units] In Commercial Distribution |
| GS1 | 20876604001705 [Package] Contains: 10876604001708 Package: Case [4 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2017-03-15 |
| 20876604001705 | Standard Bore Extension Set |
| 20876604001446 | 10” Standard Bore Extension Set w/0.22 Micron Filter |