DEVICE: ICU Medical (00887709120822)

Device Identifier (DI) Information

ICU Medical
42801-36
In Commercial Distribution
42801-36
ICU MEDICAL, INC.
00887709120822
GS1

1
118380146 *Terms of Use
Transpac IT Monitoring Kit, 24" Safeset Reservoir, Needleless Valve, 3ml Flush Device, Un-Bonded Macrodrip
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
45275 Invasive blood pressure transducer set
A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device 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
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FDA Product Code

[?]
Product Code Product Code Name
DRS Transducer, blood-pressure, extravascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052828 000
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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
No Device Sizes
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Device Record Status

4351a332-0b02-43fc-8086-508b63e7b020
September 06, 2021
1
August 29, 2021
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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
10887709120829 20 00887709120822 In Commercial Distribution CS
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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(866)829-9025
customerservice@icumed.com
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