DEVICE: Pulmoguard (B279F0102040)

Device Identifier (DI) Information

Pulmoguard
Cardboard Mouthpiece & Klip
In Commercial Distribution
F0102-040
S D I DIAGNOSTICS INC
B279F0102040
HIBCC

40
037690120 *Terms of Use
Bacterial Filter
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
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 kit A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CAH Filter, Bacterial, Breathing-Circuit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K934509 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

7bbff367-33ee-42c0-824d-9b145da22af2
July 06, 2018
3
September 13, 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: B279F01020401 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
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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