DEVICE: Curaplex (00812574026405)

Device Identifier (DI) Information

Curaplex
301-PFR9WE2
In Commercial Distribution

TRI-ANIM HEALTH SERVICES, INC.
00812574026405
GS1

1
010712461 *Terms of Use
FILTER,ELLIPTICAL,27.0ID,30.1OD
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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
Lumen/Inner Diameter: 25.4 Millimeter
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Device Record Status

5a0b4786-25e4-4636-b974-3f226d25702a
July 06, 2018
3
February 06, 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
00812574026757 100 00812574026405 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)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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