DEVICE: Chart, X-Ref Spirotech S010-06, 8.5" x 11",Grn (00817081025545)
Device Identifier (DI) Information
Chart, X-Ref Spirotech S010-06, 8.5" x 11",Grn
Chart, X-Ref Spirotech S010-06 - 133800
In Commercial Distribution
133800
A-M SYSTEMS, LLC
Chart, X-Ref Spirotech S010-06 - 133800
In Commercial Distribution
133800
A-M SYSTEMS, LLC
Chart, X-Ref Spirotech S010-06, 8.5" x 11",Grn
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
34937 | Paper chart recorder |
A mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DSF | Recorder, Paper Chart |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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
6c9cbaef-4c43-4ca9-a8ed-71d31e5a28e2
March 31, 2020
1
March 23, 2020
March 31, 2020
1
March 23, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00817081025552 | 100 | 00817081025545 | 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