DEVICE: PowerFlow (00801741136634)
Device Identifier (DI) Information
PowerFlow
AIV14
In Commercial Distribution
AIV14
Bard Access Systems, Inc.
AIV14
In Commercial Distribution
AIV14
Bard Access Systems, Inc.
PowerFlow IV Port Access System, 14G
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
58091 | Apheresis kit |
A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PTD | Subcutaneous implanted apheresis port |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 20 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Needle Gauge: 14 Gauge |
Length: 1.75 Inch |
Device Record Status
2f04558d-29a2-41f2-a275-9105b13274df
August 26, 2024
3
July 05, 2017
August 26, 2024
3
July 05, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10801741136631 | 5 | 00801741136634 | In Commercial Distribution | CA | |
20801741136638 | 2 | 10801741136631 | In Commercial Distribution | BX |
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(800)545-0890
medical.services@crbard.com
medical.services@crbard.com