DEVICE: Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton (00817081028287)
Device Identifier (DI) Information
Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton
Disposable White PFT Nose Clip with Rubber Pads - 166004
In Commercial Distribution
166004
A-M SYSTEMS, LLC
Disposable White PFT Nose Clip with Rubber Pads - 166004
In Commercial Distribution
166004
A-M SYSTEMS, LLC
Disposable White Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
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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? |
---|---|---|---|---|
10907 | Nose clip, single-use |
A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BXJ | Clip, Nose |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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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No Device Sizes |
Device Record Status
065171d6-43f4-4d44-8ba9-953e2f7596ca
March 05, 2025
1
February 25, 2025
March 05, 2025
1
February 25, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00817081028294 | 100 | 00817081028287 | 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
[?]
3606838300
sales@a-msystems.com
sales@a-msystems.com