primePICC
GUDID 20813623010189
4F x 50cm Dual Lumen CT PICC Nursing Kit
PFM MEDICAL INCORPORATED
Peripherally-inserted central venous catheter| Primary Device ID | 20813623010189 |
| NIH Device Record Key | a5d4ba09-bc86-400c-bab7-b0336b54c120 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | primePICC |
| Version Model Number | PFM2CT4DP |
| Company DUNS | 097736867 |
| Company Name | PFM MEDICAL INCORPORATED |
| 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 |
Customer Support Contacts
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813623010185 [Primary] |
| GS1 | 10813623010182 [Package] Contains: 00813623010185 Package: Inner Pack [5 Units] In Commercial Distribution |
| GS1 | 20813623010189 [Package] Contains: 10813623010182 Package: Case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072391
FDA Product Code
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-08 |
| Device Publish Date | 2019-07-31 |
On-Brand Devices [primePICC]
| 20813623013821 | 6F (2.00mm) x 60cm TRIPLE LUMEN CT PICC OTW KIT |
| 20813623013791 | 5F (1.67mm) x 55cm TRIPLE LUMEN CT PICC OTW KIT |
| 20813623013760 | 6F (2.00mm) x 60cm DUAL LUMEN CT PICC OTW KIT |
| 20813623013739 | 5F (1.67mm) x 55cm DUAL LUMEN CT PICC OTW KIT |
| 20813623013708 | 5F (1.67mm) x 55cm SINGLE LUMEN CT OTW WIRE KIT |
| 20813623013647 | 4F (1.33mm) x 50cm SINGLE LUMEN CT PICC OTW KIT |
| 20813623013616 | 3F (1.00mm) x 45cm SINGLE LUMEN CT PICC OTW KIT |
| 20813623010189 | 4F x 50cm Dual Lumen CT PICC Nursing Kit |
| 20813623010172 | 4F x 50cm Single Lumen CT PICC Nursing Kit |
| 20813623010165 | 3F x 45cm Single Lumen CT PICC Nursing Kit |
Trademark Results [primePICC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIMEPICC 87104568 5178368 Live/Registered |
PFM Medical, Inc. 2016-07-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.