DEVICE: Y-piece 7 mm Disposable System (07612367015318)

Device Identifier (DI) Information

Y-piece 7 mm Disposable System
077.0098
In Commercial Distribution

Medela AG
07612367015318
GS1

10
488293218 *Terms of Use
Connector for disposable system
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical suction system collection container, single-use A cylindrical or bottle-shaped sealable container made of glass or plastic (typically chemical resistant) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal or diagnostic/therapeutic purposes. It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use 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 [?]
K130123 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

603c2760-4c1b-4370-8454-a4bcd6854c62
August 23, 2018
4
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: 07612367051347 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
Yes
No CLOSE

Customer Contact

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