DEVICE: Evotech (10705037013340)
Device Identifier (DI) Information
Evotech
905601
In Commercial Distribution
905601
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
905601
In Commercial Distribution
905601
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Channel Separator PNTX
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
64640 | Endoscope channel-opening adaptor |
A small device intended to be manually attached to an endoscope channel/port (e.g., air/water channel, venting port), or an endoscope channel-opening button, to keep the channel open during sterilization/disinfection, typically to allow the luminal flow of a gas/solution or for pressure equalization between the endoscope interior and exterior (sterilizer chamber) to prevent damage. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FEB | ACCESSORIES, CLEANING, FOR ENDOSCOPE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K082392 | 000 |
K140977 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
00405570-1772-41d6-bc60-f827b8ff6c21
August 16, 2023
5
September 24, 2016
August 16, 2023
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(888)783-7723
ASP-Complaints@asp.com
ASP-Complaints@asp.com