DEVICE: Tube Organiser (05051223004424)

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Device Identifier (DI) Information

Tube Organiser
PS5100
PS5100
PURPLE SURGICAL INTERNATIONAL LIMITED
05051223004424
GS1
1
The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the Tube organiser helps ensure the surgical work area is kept free of the potential of trip and entanglement hazards associated with loose tubing during procedures, and aids prevention of kinking and possible occlusion.
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Device Characteristics

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

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

GMDN Preferred Term Name GMDN Definition
Universal patient tubing holder, sterile A small, sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
BYX Tubing, Pressure And Accessories
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Sterilization

Yes
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
Device Size Text, specify: 110mm length x 15mm width
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Device Status

In Commercial Distribution
September 17, 2016

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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
55051223004429 100 35051223004425 In Commercial Distribution shipping carton
35051223004425 25 05051223004424 In Commercial Distribution shelf box
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+441923839333
mail@purplesurgical.com
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