DEVICE: INVOS (30884521211159)

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Device Identifier (DI) Information

INVOS
SAFB-SM/USA
SAFB-SM/USA
Covidien LP
30884521211159
GS1
1
Adult SomaSensor Adult Disposable Regional Oxygen Saturation Sensor
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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
Cerebral oximeter sensor A photoelectric device that is applied externally to the scalp/head of a paediatric or adult patient for transcutaneous measurement of the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is connected to a cerebral oximeter via a fibreoptic cable. It typically has dual detectors, e.g., position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MUD Oximeter, tissue saturation
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: ;
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Patient Weight,> 40,Kilogram;
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Device Status

In Commercial Distribution
September 24, 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
20884521211152 20 30884521211159 In Commercial Distribution PACK_OR_INNER_PACK
10884521552685 1120 30884521211159 In Commercial Distribution CASE
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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
No
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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