DEVICE: PTS-X™ (04046964511998)
Device Identifier (DI) Information
PTS-X™
613733
Not in Commercial Distribution
613733
B BRAUN INTERVENTIONAL SYSTEMS, INC
613733
Not in Commercial Distribution
613733
B BRAUN INTERVENTIONAL SYSTEMS, INC
PTSX122 PTSX BALLOON 12MM X 2CM X 80CM
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? |
---|---|---|---|---|
42417 | Cardiac sizing catheter |
A sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MJN | Catheter, intravascular occluding, temporary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: ROOM TEMP AWAY FROM SUNLIGHT |
Special Storage Condition, Specify: KEEP DRY |
Special Storage Condition, Specify: |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5daf6e91-2f97-458f-abe4-2a348996e9ef
November 02, 2022
4
August 09, 2016
November 02, 2022
4
August 09, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com