DEVICE: Safety device plugged into pump (07612367004138)

Device Identifier (DI) Information

Safety device plugged into pump
077.0711
In Commercial Distribution

Medela AG
07612367004138
GS1

1
488293218 *Terms of Use
Safety set for Basic and Dominat Flex as well as Basic 30 and Dominant 50
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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.
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FDA Product Code

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Product Code Product Code Name
BTA Pump, Portable, Aspiration (Manual Or Powered)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

78f92458-e8a7-4aaa-b683-bc4edbd11a7b
March 29, 2018
2
October 03, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
+1-877-735-1626
info-healthcare@medela.com
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