| Primary Device ID | 10850005864131 |
| NIH Device Record Key | 775e10d0-a5c5-44dd-a167-9dc2156e99fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FK20203E |
| Version Model Number | FK20203E |
| 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 | 00850005864134 [Primary] |
| GS1 | 10850005864131 [Package] Contains: 00850005864134 Package: [100 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 | 2019-04-05 |
| Device Publish Date | 2019-03-28 |
| 20850005864640 - PS-84320 | 2019-11-18 20G X 1.88" IV CATHETER PURSAFETY S |
| 20850005864619 - PS-843242 | 2019-11-13 24GX .56" IV CATHETER PURSAFETY S |
| 20850005864626 - PS-84326 | 2019-11-13 26GX 56" IV CATHETER PURSAFETY S |
| 20850005864633 - PS-843262 | 2019-11-13 26GX.75" IV CATHETER PURSAFETY S |
| 00850005864561 - BASNWS -30/150 | 2019-09-24 Administration Set, NO Spike, 150 Micron Filter, 30cc Syringe |
| 10850005864605 - BMS-2135.17S | 2019-09-17 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock, |
| 10850005864575 - BM-2135.17 | 2019-09-13 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock |
| 10850005864582 - 002231 | 2019-09-13 Extension Set, 6" w/ 3-way stopcock |