DEVICE: Hi-Vac Tubing (00081317023449)

Device Identifier (DI) Information

Hi-Vac Tubing
B5558
In Commercial Distribution
B5558
MENTOR TEXAS L.P.
00081317023449
GS1

1
167450993 *Terms of Use
Hi-Vac Tubing
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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
Suction system tubing A flexible, hollow, cylindrical device, typically made of synthetic material, used to connect a suction catheter to a collection bottle/canister, a collection canister/bottle to a regulator/suction pump, or to connect a series of collection bottles/canisters to increase to total capacity within a suction system. This device can come in rolls from which required lengths are cut, or in predetermined lengths with built-in connectors. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KGZ ACCESSORIES, CATHETER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

c40992d2-e83c-438c-9486-42f4758e67e0
March 29, 2018
2
September 14, 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
10081317023446 10 00081317023449 In Commercial Distribution 10 Pouches/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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)235-5731
xx@xx.xx
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