DEVICE: Curaplex (00812574026221)

Device Identifier (DI) Information

Curaplex
301-005-10010
In Commercial Distribution

TRI-ANIM HEALTH SERVICES, INC.
00812574026221
GS1

1
010712461 *Terms of Use
HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 50/CA
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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
Pleural drainage system An assembly of sterile devices intended to be used for the aspiration of air/fluid from the pleural cavity (potential space between the serous membranes covering the lungs) by means of suction. It includes a pleural catheter, a water seal (underwater) drainage unit, typically with three separate chambers, and typically a suction system regulator, intended to be connected to the hospital's central vacuum system; it does not include pharmaceuticals. This system is usually used to restore normal lung function following chest or mediastinal surgery (e.g., open heart surgery), or to treat conditions such as pneumothorax and/or haemothorax. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
JOL CATHETER AND TIP, SUCTION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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

6ea9d9e4-3f98-42c4-8337-2d87a719884b
March 29, 2018
2
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
00812574026573 50 00812574026221 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
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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