DEVICE: DTX(TM) PLUS DT-4812NA (00886333620036)
Device Identifier (DI) Information
DTX(TM) PLUS DT-4812NA
682003
In Commercial Distribution
682003
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682003
In Commercial Distribution
682003
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
A 3cc transducer connected with a 48" & a 12" Pressure Tubings
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? |
---|---|---|---|---|
35927 | Invasive-pressure external transducer, single-use |
A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXN | System, Measurement, Blood-Pressure, Non-Invasive |
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 |
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Device Size Text, specify: 3cc Transducer |
Device Record Status
6e3236ed-7f6a-4aac-afd0-62721eab2845
June 11, 2018
3
September 30, 2016
June 11, 2018
3
September 30, 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 |
---|---|---|---|---|---|
50886333620031 | 50 | 00886333620036 | In Commercial Distribution | Tyvek Pouch |
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
[?]
1.800.927.4669
Customer.Service@argonmedical.com
Customer.Service@argonmedical.com