DEVICE: Injectate temperature sensor housing (04250094500153)

Device Identifier (DI) Information

Injectate temperature sensor housing
PV4046
In Commercial Distribution

Pulsion Medical Systems SE
04250094500153
GS1

1
316093673 *Terms of Use
Injectate temperature sensor housing PV4046
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Thermal-dilution cardiac output unit A unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.
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FDA Product Code

[?]
Product Code Product Code Name
KRB Probe, Thermodilution
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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
No Device Sizes
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Device Record Status

cbd27168-8107-4cd1-a840-90bc0220ac6a
March 29, 2018
2
September 29, 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
24250094500157 10 04250094500153 In Commercial Distribution Box
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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
Yes
No CLOSE

Customer Contact

[?]
+490894599140
info@pulsion.com
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