DEVICE: Curaplex (00812574026399)
Device Identifier (DI) Information
Curaplex
301-PFR9WC
In Commercial Distribution
TRI-ANIM HEALTH SERVICES, INC.
301-PFR9WC
In Commercial Distribution
TRI-ANIM HEALTH SERVICES, INC.
FILTER,C/B M/P,27.0ID,30.1OD
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
61097 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZG | SPIROMETER, DIAGNOSTIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K042758 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 25.4 Millimeter |
Device Record Status
d1cec317-03d1-455f-bc04-99e051164124
July 06, 2018
3
February 06, 2017
July 06, 2018
3
February 06, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00812574026740 | 100 | 00812574026399 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined