DEVICE: Getinge 800 Series (05902533505654)
Device Identifier (DI) Information
Getinge 800 Series
833HC
In Commercial Distribution
8SEVUTHPAAAA
GETINGE IC PRODUCTION POLAND SP Z O O
833HC
In Commercial Distribution
8SEVUTHPAAAA
GETINGE IC PRODUCTION POLAND SP Z O O
Steam Sterilizer - 833HC-E,L1,DDLHRH,DU,PPM,RLR
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
38671 | Steam sterilizer |
A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FLE | Sterilizer, Steam |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K122625 | 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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No Device Sizes |
Device Record Status
959c9a2d-6b4f-4d26-a17b-397f0da3c77b
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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