DEVICE: INTROCAN SAFETY® (04046964381997)
Device Identifier (DI) Information
INTROCAN SAFETY®
4254562-020
In Commercial Distribution
4254562-020
B. BRAUN MEDICAL INC.
4254562-020
In Commercial Distribution
4254562-020
B. BRAUN MEDICAL INC.
INTROCAN SAFETY-W FEP 18G, 1.3X32MM-US
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
32151 | Peripheral vascular intervention infusion catheter |
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | INTRODUCER, CATHETER |
FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Catheter-Gauge : 18 |
Device Record Status
497026d4-41ab-40cb-9843-c9c2a62c0d5e
June 10, 2022
13
September 23, 2016
June 10, 2022
13
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04046964382109 | 4 | 04046964381997 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046964381980
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
BBMUS_Service.EmailOrders@bbraun.com