| Primary Device ID | 10812608020253 |
| NIH Device Record Key | 1807dedb-fd2d-4736-bcd5-7ba178979ffd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PMI |
| Version Model Number | PMISG12B2 |
| Catalog Number | PMISG12B2 |
| Company DUNS | 192135242 |
| Company Name | PROGRESSIVE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812608020256 [Primary] |
| GS1 | 10812608020253 [Package] Contains: 00812608020256 Package: BOX [4 Units] In Commercial Distribution |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10812608020253]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10812608020253]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10812608020253]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10812608020253]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10812608020253]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10812608020253]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10812608020253]
Moist Heat or Steam Sterilization;Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2016-09-23 |
| 00812608021840 | PMI IV admin set with flow regulator and needle-free y-site approx. 11" from distal end, 100" le |
| 00812608021826 | PMI Pharmacy Pump Set, dual tubing with spikes & luer lock distal ends |
| 00812608021765 | PMI IV Start Kit |
| 00812608021741 | PMI Disposable Operative Cholangiogram Catheter 20" for percutaneous insertion |
| 10812608021724 | PMI Empty IV Bag 150 mL; 2 ports |
| 10812608021700 | PMI Empty IV Bag 1000mL; 2 ports |
| 00812608021680 | PMI Empty IV Bag 500mL; 2 ports |
| 00812608021666 | PMI Empty IV Bag 250mL; 2 ports |
| 00812608021635 | PMI Empty IV Bag 100mL; 2 ports |
| 00812608021604 | PMI Empty IV Bag 50mL; 2 ports |
| 10812608021588 | PMI Cholangiogram Grasper Stainless Steel Replacement Cap - Reusable |
| 10812608021571 | PMI Extractor-EZ is a disposable instrument with a retractable blade designed to enlarge the fas |
| 00812608021550 | PMI Cholangiogram Combo Pack Includes: (PMIXL11) Disposable Operative Cholangiogram Catheter 11 |
| 00812608021536 | PMI Cholangiogram Combo Pack Includes: Disposable Operative Cholangiogram Catheter 20" and (PMI |
| 00812608021499 | PMI Insufflation Needle 150mm (14 ga) |
| 00812608021475 | PMI Insufflation Needle 120mm (14ga) |
| 00812608021451 | PMI LATEX FREE DRESSING CHANGE KIT WITH CHLORAPREP |
| 00812608021437 | LACERATION TRAY W/SERRATED FORCEP |
| 00812608021413 | PMI IV START KIT W/CHLORAPREP LATEX FREE |
| 00812608021390 | PMI IV START KIT W/ PVP LATEX FREE |
| 00812608021376 | PMI Cholangiogram Grasper, Standard |
| 00812608021338 | PMI Pharmacy pump set, straight with spike and luer lock distal end |
| 00812608021314 | PMI Cholangiogram Grasper, Bariatric |
| 00812608021307 | PMI IV admin set with flow regulator, 100" length, 20 drop, 15 micron filter in drip chamber, ro |
| 10812608021281 | PMI Huber Safety Infusion Set 22G x 1 ½” Needle, Needle-Free Y-Site, 8" tub |
| 10812608021274 | PMI Huber Safety Infusion Set 22G x 1” Needle, Needle-Free Y-Site, 8" tubin |
| 10812608021267 | PMI Huber Safety Infusion Set 20G x 1 ½” Needle, Needle-Free Y-Site, 8" tubing |
| 10812608021250 | PMI Huber Safety Infusion Set 20G x 1” Needle, Needle-Free Y-Site, 8" tubing |
| 10812608021243 | PMI Huber Safety Infusion Set 19G x ¾” Needle, Needle-Free Y-Site, 8" tubing |
| 10812608021236 | PMI Huber Safety Infusion Set 19G x 1 ½” Needle, Needle-Free Y-Site, 8" tub |
| 10812608021229 | PMI Huber Safety Infusion Set 19G x 1” Needle, Needle-Free Y-Site, 8" tubin |
| 10812608021168 | PMI Huber Safety Infusion Set 22G x ½” Needle, 6" tubing |
| 10812608021151 | PMI Huber Safety Infusion Set 22G x ¾” Needle, 6" tubing |
| 10812608021144 | PMI Huber Safety Infusion Set 22G x 1 ½” Needle, 6" tubing |
| 00812608021130 | PMI Huber Safety Infusion Set 22G x 1” Needle, 6" tubing |
| 10812608021120 | PMI Huber Safety Infusion Set 20G x ½" Needle, 6" Tubing |
| 10812608021113 | PMI Huber Safety Infusion Set 19G x ¾” Needle, 6" tubing |
| 10812608021106 | PMI Huber Safety Infusion Set 19G x 1 ½” Needle, 6" tubing |
| 10812608021090 | PMI Huber Safety Infusion Set 19G x 1” Needle, 6" tubing |
| 10812608021083 | PMI Huber Safety Infusion Set, 20G x 1 ½” Needle, 6" tubing |
| 10812608021076 | PMI Huber Safety Infusion Set 22G x ¾” Needle, Needle-Free Y-Site, 8" Tubin |
| 10812608021069 | PMI Operative Cholangiogram Catheter; tubing is 76cm in length, 16ga with a |
| 10812608021052 | PMI Disposable Puncture Closure Device / Suture Grasper |
| 10812608021045 | PMI Pneumoperitoneum Insufflation Needle 12cm |
| 10812608021038 | PMI Disposable Percutaneous Introducer (4” length- 14g); |
| 10812608021021 | PMI Disposable Cholangiogram Catheter 13"; for port insertion |
| 10812608021014 | PMI Disposable Cholangiograph Catheter 7", for traditional open procedure |
| 10812608021007 | PMI Disposable Cholangiogram Catheter 11"; for percutaneous insertion |
| 10812608020994 | PMI Combo Pack Includes: Disposable Lap Cholangiography Catheter (PMIXL11) |
| 10812608020987 | For Percutaneous Insertion, Combo Pack Includes:(PMIORCA20) Disposable Operative Cholangiogram C |