| Primary Device ID | 10850005864414 |
| NIH Device Record Key | 38f60fe5-5db3-4ab9-bd14-501dfe2a1861 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PMGF090NY |
| Version Model Number | PMGF090NY |
| 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 | 00850005864417 [Primary] |
| GS1 | 10850005864414 [Package] Contains: 00850005864417 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 |
| 10850005864414 | 90" Flow regulator, 1 needle free Y site, 8" above distal tip, pinch clamp,.22 micron filter, ma |
| 10850005864407 | 90" Flow regulator, pinch clamp, male spin luer lock |