DEVICE: VACUTRON (00260720007189)

Device Identifier (DI) Information

VACUTRON
MINI-VAC
In Commercial Distribution
22-15-1102
ALLIED HEALTHCARE PRODUCTS, INC.
00260720007189
GS1

1
099674145 *Terms of Use
CONTINUOUS / INTERMITTENT SUCTION REGULATORS
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Tracheal suction vacuum regulator A device designed to connect to the vacuum terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure (vacuum) provided by the system and applied in the evacuation of fluids, mucus or solids from the trachea. The device is connected either directly or via dedicated vacuum tubing to the wall outlet and helps provide continuous or intermittent suction at variable levels. It is typically constructed of metal and plastic and includes a manometer for monitoring suction/vacuum pressure. It may include a disposable antibacterial filter, a collection bottle and a mechanical anti-overflow mechanism to help protect the device and the vacuum pipeline system.
Neurosurgical suction regulator A device designed to be attached to a suction system to control the degree of negative pressure (suction) applied in the evacuation of fluids, solids, or gases from the body during a neurosurgical procedure where the precise level of suction can be critical, e.g., during cranial surgery. The device is typically mounted onto the suction system and is connected with tubing between the suction system's pump and the collection container; it has two or more pre-set levels that are selected by the operator (the surgeon) using a foot-switch.
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FDA Product Code

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Product Code Product Code Name
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
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FDA Premarket Submission

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

No
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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

9662a2b6-6b42-48ba-a8df-233b30e594b9
March 29, 2018
2
September 12, 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
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)

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None
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Production Identifier(s) in UDI

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Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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