DEVICE: NA (00606959024229)

Device Identifier (DI) Information

NA
00
In Commercial Distribution
1074610
Respironics, Inc.
00606959024229
GS1
December 31, 9999
1
080728314 *Terms of Use
Disposable Pediatric, Active Circuit with Water Trap
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Breathing circuit tube A hollow tubular device made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases during the respiratory cycle, typically during anaesthesia or ventilation. It is intended to function as part of, or in association with, a breathing circuit or other gas delivery device (e.g., respiratory mask) and/or connect to a breathing bag or ventilator. It may be used as a gas pressure line. This is a reusable device intended to be cleaned/disinfected prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
CBK VENTILATOR, CONTINUOUS, FACILITY USE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K093416 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 -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

bdcc7a46-0302-43a1-a824-1b87acb59bf6
July 06, 2018
3
October 23, 2015
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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
30606959024220 10 00606959024229 1999-12-31 Not in Commercial Distribution PACK_OR_INNER_PACK
40606959024227 20 00606959024229 1999-12-31 Not in Commercial Distribution PACK_OR_INNER_PACK
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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(724)744-2500
respironics.service@philips.com
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