DEVICE: Suction Jar Polysulfone, 1l (07612367002691)
Device Identifier (DI) Information
Suction Jar Polysulfone, 1l
077.0110
In Commercial Distribution
Medela AG
077.0110
In Commercial Distribution
Medela AG
Suction jar for reusable collection system
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Suction system canister, reusable | A cylindrical sealable container typically made of hard plastic materials used as a component of a suction system, or other system that utilizes suction, and which is designed for the collection of aspirated waste materials (e.g., blood, bodily fluids, rinsing fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. This device is typically used in conjunction with a dedicated disposable liner that confines and stores the contaminated waste, and may be used singularly or in a connected series to provide greater capacity. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTA | Pump, Portable, Aspiration (Manual Or Powered) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130123 | 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
98526da3-3d93-424c-a3d0-29a2aa4cb12e
July 06, 2018
3
October 24, 2016
July 06, 2018
3
October 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 |
---|---|---|---|---|---|
07612367037938 | 16 | 07612367002691 | In Commercial Distribution |
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
[?]
+1-877-735-1626
info-healthcare@medela.com
info-healthcare@medela.com