| Primary Device ID | 10850005864506 |
| NIH Device Record Key | d5acc0ef-a8a9-4e5c-81fc-2b1bc6393d9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PMG0083 |
| Version Model Number | PMG0083 |
| Company DUNS | 042928915 |
| Company Name | PATHEN MEDICAL LLC |
| 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 | 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 |
| Phone | 8773185421 |
| questions@pathen.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005864509 [Primary] |
| GS1 | 10850005864506 [Package] Contains: 00850005864509 Package: [50 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-23 |
| Device Publish Date | 2019-07-15 |
| 10850005864506 | 84” 10 drop, vented/non-vented drip chamber, roller clamp, pre-slit Y-site, needleless Y-site |
| 10850005864490 | 83” 15 drop, non-vented drip chamber, roller clamp, pre-slit Y-site, needleless Y-site connect |