DEVICE: Venti-Scan (00718175001929)

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Device Record History
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Device Identifier (DI) Information
Venti-Scan
177-092
In Commercial Distribution
177-092
BIODEX MEDICAL SYSTEMS, INC.
00718175001929
GS1

1
043833813 *Terms of Use
Venti-Scan 24" Tubing
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16784 Radioaerosol administration set
A collection of devices used to quickly deliver radioaerosol to a patient for ventilatory pulmonary scintigraphy. It is used with an aerosol pump/nebulizer or a compressed air line to generate the radioactive aerosol, and a lead (Pb) protective container to hold the radioactive solution during the inhalation procedure. It typically consists of one or several one-way valves to direct the flow of aerosol to the patient, transport tubing to carry the aerosol to the patient, a mouthpiece, and a bacteria filter to trap any exhaled aerosol. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
IYT System, Rebreathing, Radionuclide
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K871868 000
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Sterilization
No
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
2554a067-ed1c-4aee-8ed8-207f12d320d2
October 24, 2018
3
November 02, 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
30718175001951 50 00718175001929 In Commercial Distribution Box
20718175001947 25 00718175001929 In Commercial Distribution BOX
10718175001933 10 00718175001929 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
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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