DEVICE: N/A (00607411920127)

Device Identifier (DI) Information

N/A
5055-7
In Commercial Distribution
5055-7
SALTER LABS
00607411920127
GS1

1
022721133 *Terms of Use
Small pediatric oral/nasal pressure monitoring and gas sampling cannula
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
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?
35194 Respiratory apnoea monitoring system
An assembly of devices designed to detect the cessation of breathing (apnoea) in infants and adults who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). It alarms primarily upon the cessation of breathing timed from the last detected breath, and may also include indirect methods of apnoea detection such as monitoring of heart rate and other physiological parameters associated with respiration. It may print-out this data. It will typically include a mains electricity (AC-powered) monitoring unit with software, patient leads, and possibly a recorder to record, display, or print data on a patient's breathing condition.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MNR VENTILATORY EFFORT RECORDER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K051313 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Pediatric
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Device Record Status

ee987686-7560-41e6-a4b5-9a95f127b04a
July 06, 2018
3
October 10, 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
10607411920124 25 00607411920127 In Commercial Distribution
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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
No
No CLOSE

Customer Contact

[?]
+1(800)421-0024
customercare@salterlabs.com
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