DEVICE: Curaplex (00812574026498)

Device Identifier (DI) Information

Curaplex
301-P3600EA
In Commercial Distribution

TRI-ANIM HEALTH SERVICES, INC.
00812574026498
GS1

1
010712461 *Terms of Use
DIVIDED CANNULA,7'*,MLUER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Carbon-dioxide-sampling 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 simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151421 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bf14ff7b-21da-40b9-9731-466712bf4825
July 06, 2018
3
February 06, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00812574026849 25 00812574026498 In Commercial Distribution
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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

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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

[?]
No Customer Contact currently defined
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