Picc Wand
PICC Wand is a preassembled catheter introducer that combines an introducer needle, nitinol guidewire, dilator and peelable sheath. It creates access for placement of a peripherally…
PICC Wand is a preassembled catheter introducer that combines an introducer needle, nitinol guidewire, dilator and peelable sheath. It creates access for placement of a peripherally inserted central catheter or midline catheter.
The needle establishes vascular access, while the guidewire, dilator and sheath provide the pathway for catheter placement. The peelable sheath allows removal around the catheter after it has been introduced.
Listed Item
The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
Access Features
A Fast-flash feature gives visible feedback when the needle is within the vessel. An integral safety mechanism guards the needle to reduce accidental needle-stick exposure. The family includes 4, 5 and 6 Fr sheath configurations and is supplied in a formed tray with a Tyvek lid.
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Access Scientific, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| 510(k) | K111138 |
| Record published | 2016-09-09 |
| Record revised | 2024-03-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from direct contact with sun, water and humidity; Storage environment temperature 32 to 104 °F |
| Packaging | Overpack of 18, carton of 10 |
| Sizes | Length 7 to 7.25 cm; catheter gauge 4 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4Fr | Length 7.25 cm | In distribution |
| 6Fr | Length 7 cm | In distribution |
| 5Fr | Length 7.25 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183066 | 2019-07-25 |
| K182243 | 2018-09-18 |
| K162322 | 2016-11-17 |
| K131148 | 2013-09-04 |
| K131300 | 2013-06-07 |
| K121748 | 2012-07-27 |
| K111417 | 2011-07-15 |
| K111138 | 2011-06-22 |
| K101422 | 2011-03-22 |
| K101150 | 2010-08-13 |
| K093022 | 2010-01-20 |
| K090372 | 2009-03-30 |
| K081697 | 2008-12-04 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-08-16 | Class II | Labeling Change Control | Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. | 160 units | 2013-09-24 |
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.