DEVICE: MGC Diagnostics (B3685367130010)

Device Identifier (DI) Information

MGC Diagnostics
536713-001
In Commercial Distribution
536713-001
MEDICAL GRAPHICS CORPORATION
B3685367130010
HIBCC

1
094045622 *Terms of Use
preVent Filter
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Pulmonary function testing filter/mouthpiece A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
BZG Spirometer, Diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042758 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

be6ca7a7-41eb-4d6b-83d2-0b2ff3047f08
July 06, 2018
3
January 12, 2017
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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
536713001 100 B3685367130010 In Commercial Distribution Carton
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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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