DEVICE: Merit Medical® (10884450628307)
Device Identifier (DI) Information
Merit Medical®
B
In Commercial Distribution
682106
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
B
In Commercial Distribution
682106
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
35529 | Invasive blood pressure monitoring tubing set |
A collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FPK | Tubing, fluid delivery |
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: Length-25 cm |
Device Record Status
1c9bbf45-f8dd-4c6a-9061-2a032514e580
December 16, 2024
1
December 07, 2024
December 16, 2024
1
December 07, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884450628304 | 5 | 10884450628307 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00884450628300
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined