DEVICE: Trulink (10841522126253)

Device Identifier (DI) Information

Trulink
NIBP Hoses and adapters
In Commercial Distribution
704-0004
SPACELABS HEALTHCARE (WASHINGTON), INC
10841522126253
GS1

1
145581588 *Terms of Use
AIRWAY,ADAPTER,CO2,NEO,SPU
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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?
37021 Anaesthesia breathing circuit, reusable
An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031124 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 0-4mm OD
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Device Record Status

863fb4ff-257e-46cb-ac1c-1b317eda67b3
September 02, 2024
4
December 11, 2019
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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
30841522126257 24 10841522126253 In Commercial Distribution BX
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Secondary DI

[?]
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
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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