DEVICE: PTAFLITE (00606959006119)

Device Identifier (DI) Information

PTAFLITE
PTAF LITE
In Commercial Distribution
P1304R
Respironics, Inc.
00606959006119
GS1
December 31, 9999
1
080728314 *Terms of Use
PTAF Lite, Unfiltered AF only
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Basic nasal oxygen cannula A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.
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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 [?]
K982293 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 Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4d3daef0-00f1-4096-935b-38c379706012
July 06, 2018
3
September 18, 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
No Package DIs found
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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(724)744-2500
respironics.service@philips.com
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