DEVICE: Curaplex (00817617021386)

Device Identifier (DI) Information

Curaplex
8600-01181
In Commercial Distribution

BOUND TREE MEDICAL, LLC
00817617021386
GS1

1
070556204 *Terms of Use
*Custom* City of Joliet Chest Decompression Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
First aid gauze/bandage A sterile wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is typically used to protect wounds, arrest bleeding, and introduce medications placed on the pad. It is available [non-prescription] over-the-counter (OTC) for use in the home or clinical settings. This is a single-use device.
Antiseptic swab A device that is pre-soaked with an antiseptic and intended to inhibit the growth of microorganisms on the skin; it may also include an anaesthetic to alleviate pain. It is typically designed as a sterile cotton swab (a pledget) on a plastic stick and used in the hospital environment, in the home, or carried for first aid to prevent infection and provide temporary pain and itching relief associated with minor cuts, scrapes, or burns. This is a single-use device.
Non-woven gauze pad, sterile A non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.
Pleural catheter A sterile, tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FOZ Catheter,intravascular,therapeutic,short-term less than 30 days
KDQ BOTTLE, COLLECTION, VACUUM
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FDA Premarket Submission

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

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

63fb4619-e9fb-4615-afc8-9ca2ea1162eb
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
No Package DIs found
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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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