Picc Prime
6F (2.00mm) x 60cm TRIPLE LUMEN CT PICC NURSING KIT
5manufacturers in China registered for this device type
13catalogue numbers in this listing
3510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | PFM Medical, Inc, United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K110914 |
| Record published | 2017-01-19 |
| Record revised | 2021-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PFM2CT6TN | In distribution | |
| PFM2CT4S | In distribution | |
| PFM2CT5D | In distribution | |
| PFM2CT4SN | In distribution | |
| PFM2CT5S | In distribution | |
| PFM2CT5TN | In distribution | |
| PFM2CT6DN | In distribution | |
| PFM2CT6D | In distribution | |
| PFM2CT3S | In distribution | |
| PFM2CT5SN | In distribution | |
| PFM2CT6T | In distribution | |
| PFM2CT3SN | In distribution | |
| PFM2CT5T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110914 | 2011-09-21 |
| K083873 | 2009-03-19 |
| K072391 | 2007-11-19 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| PFM Medical, Inc | 510(k) number | 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 100 units | 2015-04-23 |
| PFM Medical, Inc | 510(k) number | 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 90 units | 2015-04-23 |
| PFM Medical, Inc | 510(k) number | 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 83 units | 2015-04-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.