DEVICE: ARROW (00801902077080)

Device Identifier (DI) Information

ARROW
IPN034164
In Commercial Distribution
ASK-00376-SU
TELEFLEX INCORPORATED
00801902077080
GS1

1
002348191 *Terms of Use
Large Volume Abdominal Paracentesis Kit with Sharps Safety Features
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
Yes
Yes
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
Pleural/peritoneal drainage catheterization kit A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KDD KIT, SURGICAL INSTRUMENT, DISPOSABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K874063 000
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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
No Device Sizes
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Device Record Status

bf32ee43-3c5e-4144-9200-bc26988d4241
July 06, 2018
4
September 16, 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
30801902077081 5 00801902077080 2018-05-09 Not in Commercial Distribution Case
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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(919)544-8000
CS@TELEFLEX.COM
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