DEVICE: PFT (15099169285511)

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Device Record History
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Device Identifier (DI) Information
PFT
2820
In Commercial Distribution

VITALOGRAPH (IRELAND) LIMITED
15099169285511
GS1

1
219683489 *Terms of Use
2820 ECO BVF + BITE-ON MOUTHPIECE +DNC
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

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?
44545 Breathing mouthpiece, single-use
A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BZG SPIROMETER, DIAGNOSTIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K942779 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
c37ef954-bd7a-4bc0-9ae0-e4916e234d72
July 06, 2023
2
June 21, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05099169285514 60 15099169285511 In Commercial Distribution
55099169285519 8 05099169285514 In Commercial Distribution
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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
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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