accessscientific.comThe POWERWAND Safety Introducer With An Extended Dwell Catheter Made Of ChronoFlex C® With BioGUARD™ Technology-3 Fr, 4 Fr, And 5 Fr Model
Access Scientific, LLC
ACCESS SCIENTIFIC, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009549229 | 3009549229 | ACCESS SCIENTIFIC, LLC | 1 | N | 2020-04-25 | 3910 Sorrento Valley Blvd Ste 200 San Diego CA US 92121 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00859821006759 | POWERWAND - Dressing Change Kit w/Statlock | 1-858-259-8333 | cs@accessscientific.com |
| 10859821006114 | CVC WAND - The CVC WAND Safety Introducer with Valved Peelabel Sheath and Integral Needle Protection | 1-858-259-8333 | cs@accessscientific.com |
| 10859821006121 | CVC WAND XL - The CVC WAND Safety Introducer with Valved Peelabel Sheath | 1-858-259-8333 | cs@accessscientific.com |
| 10859821006138 | PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection | 1-858-259-8333 | cs@accessscientific.com |
| 10859821006145 | PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection | 1-858-259-8333 | cs@accessscientific.com |
| 10859821006374 | POWERWAND - POWERWAND Dressing Change Kit with StatLock | 1-858-259-8333 | cs@accessscientific.com |
| 10859821006381 | POWERWAND - POWERWAND Dressing Change Kit with Zpad | 1-858-259-8333 | cs@accessscientific.com |
| 10859821006459 | POWERWAND - Deluxe Dressing Change Kit W/Zpad | 1-858-259-8333 | cs@accessscientific.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 150929 | 1137741655 | K973958 | GENERAL PURPOSE ATL NEEDLE GUIDE KIT | ITX | 1998-01-22 |
| 150929 | 1616089227 | K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model | DYB | 2019-07-25 |
| 150929 | 1028265025 | K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | DYB | 2018-09-18 |
| 150929 | 1942654106 | K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | DQY | 2018-09-26 |
| 150929 | 1563592855 | K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | DYB | 2016-11-17 |
| 150929 | 1389109690 | K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | 2013-06-07 |
| 150929 | 1118520700 | K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | DYB | 2013-09-04 |
| 150929 | 1222995262 | ||||
| 150929 | 1453792517 | ||||
| 150929 | 1563305302 |
Product Codes Associated With Registrations#
PMN#
The ARTERIAL WAND Safety Introducer With Arterial Catheter Made Of ChronoFlex C With BioGUARD Technology
Access Scientific, LLC
The CVC WAND Safety Introducer With Valved Peelable Sheath
Access Scientific, LLC
The POWERWAND Safety Introducer With An Extended Dwell Catheter, 3Fr. Model
ACCESS SCIENTIFIC, LLC
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
ACCESS SCIENTIFIC, LLC
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
ACCESS SCIENTIFIC, LLC
GUDID#
POWERWAND - POWERWAND Dressing Change Kit with StatLock
2016-09-09
POWERWAND - POWERWAND Dressing Change Kit with Zpad
2016-09-09
POWERWAND - Deluxe Dressing Change Kit W/Zpad
2016-09-09
POWERWAND - Dressing Change Kit w/Statlock
2019-12-12
CVC WAND - The CVC WAND Safety Introducer with Valved Peelabel Sheath and Integral Needle Protection
2016-09-09
CVC WAND XL - The CVC WAND Safety Introducer with Valved Peelabel Sheath
2016-09-09
PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
2016-09-09
PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
2016-09-09
PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
2016-09-09
PICC WAND - PICC WAND Max Barrier Kit 4Fr
2016-09-09
PICC WAND - PICC WAND Max Barrier Kit 5Fr
2016-09-09
PICC WAND - PICC WAND Max Barrier Kit 6Fr
2016-09-09
CVC WAND - The CVC WAND Safety Introducer with Valved Peelable Sheath
2018-10-11
CVC WAND XL - The CVC WAND Safety Introducer with Valved Peelable Sheath
2018-10-11
POWERWAND - POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom)
2020-03-25
POWERWAND™ XL - POWERWAND XL Maximum Barrier Kit 4Fr x 10cm without Statlock and IV Extension Set
2020-09-30
POWERWAND - POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom)
2020-03-25
POWERWAND™ XL - Pouch, PW XL 3FR 6cm (US) for Kit (40351)
2020-11-06
POWERWAND - POWERWAND™ ED 3Fr x 6cm (Custom)
2020-03-25
POWERWAND™ XL - POWERWAND XL Maximum Barrier Kit 4Fr x 10cm without Statlock and IV Extension Set
2020-09-30
POWERWAND - Dressing Change Kit w/Statlock
2019-12-12
POWERWAND™ XL Alternate Site with Needle Guide Kit - 4 Fr
2019-11-22
CVC WAND - The CVC WAND Safety Introducer with Valved Peelable Sheath
2018-10-11
CVC WAND XL - The CVC WAND Safety Introducer with Valved Peelable Sheath
2018-10-11
POWERWAND™ XL Maximum Barrier Kit - POWERWAND™ XL Maximum Barrier Kit, 4Fr x 10cm
2019-11-22
POWERWAND - POWERWAND Dressing Change Kit with StatLock
2016-09-09
POWERWAND - POWERWAND Dressing Change Kit with Zpad
2016-09-09
POWERWAND - Deluxe Dressing Change Kit W/Zpad
2016-09-09
CVC WAND - The CVC WAND Safety Introducer with Valved Peelabel Sheath and Integral Needle Protection
2016-09-09
CVC WAND XL - The CVC WAND Safety Introducer with Valved Peelabel Sheath
2016-09-09
PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
2016-09-09
PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
2016-09-09
PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
2016-09-09
PICC WAND - PICC WAND Max Barrier Kit 4Fr
2016-09-09
PICC WAND - PICC WAND Max Barrier Kit 5Fr
2016-09-09
PICC WAND - PICC WAND Max Barrier Kit 6Fr
2016-09-09
ARTERIAL WAND - The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
2018-10-11
ARTERIAL WAND - The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
2018-10-11
POWERWAND™ XL - The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm
2018-09-24
POWERWAND - The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable
2017-02-28