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.
00886333679133
GS1

1
595138793 *Terms of Use
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.
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 3 cc transducers
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Device Record Status

191e7480-31b0-4400-9ecc-d7638c78f9cd
March 29, 2018
2
September 23, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1.800.927.4669
Customer.Service@argonmedical.com
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