DEVICE: TRIPLE LINE SET WITH SAFEDRAW(TM) (00886333679133)
Device Identifier (DI) Information
TRIPLE LINE SET WITH SAFEDRAW(TM)
687913
In Commercial Distribution
687913
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
687913
In Commercial Distribution
687913
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
A 3-way 20 drops,60" tubing length each AdSet connected with 3x 3cc transducers at each end. 1 channel is connected with a septum with a 5cc syringe with touchguard stops at 2cc via a 48" & 6" Pressure Tubing & a 12" pressure Tubing from Patient. The other 2 lines connects directly to the 3cc transducer each, a 3-way stopcock and a 6" Pressure Tubing. The 3rd line has an additional 3-Way stopcock to the 6" Pressure Tubing. It includes a separately packed 4xmale & 4xfemale protective caps.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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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? |
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31336 | Arterial blood sampling kit |
A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. 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 [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 3 cc transducers |
Device Record Status
191e7480-31b0-4400-9ecc-d7638c78f9cd
March 29, 2018
2
September 23, 2016
March 29, 2018
2
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 |
---|---|---|---|---|---|
50886333679138 | 20 | 00886333679133 | In Commercial Distribution | tyvek bag |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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