DEVICE: Large Volume Paracentesis Kit (00893029002007)

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Device Identifier (DI) Information

Large Volume Paracentesis Kit
GIS-28
GIS-28
GI SUPPLY, INC.
00893029002007
GS1
1
The GI Supply Large Volume Paracentesis Kit is intended to be used in conjunction with the GI Supply Paracentesis Pump to remove ascitic fluid from the abdominal cavity. The GI Supply Paracentesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis. The Sterile Kit contains standard components required for paracentesis procedure (1) 10cc and (1) 30cc luer locking syringe, (1) filter straw, (1) 3-pack povidone-iodine swabsticks, (1) fenestrated drape, (1) 18Ga and (1) 25Ga 1-½” Needles, (2) 5ml ampuls of 1% Lidocaine, (3) 5ml printed sample vials with caps, (1) #11 blade scalpel, (1) bandage, (5) 4x4” gauze pads and (3) alcohol prep pads; along with specially designed components required to work with the RP Pump (2) 1.6L Drainage bags, (1) Pump Tube set, (1) Paracentesis Device Assembly and (1) 15Ga Needle.
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Device Characteristics

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

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
Pleurocentesis/paracentesis kit A collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LRO General Surgery Tray (Kit)
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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
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 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
10893029002004 5 00893029002007 In Commercial Distribution 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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800-451-5797
customer_service@gi-supply.com
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