DEVICE: Accessories for Vario 18 pump (07612367022910)

Device Identifier (DI) Information

Accessories for Vario 18 pump
080.0008
In Commercial Distribution

Medela AG
07612367022910
GS1

1
488293218 *Terms of Use
Accessories for Vario 18 pump consisting of disposable tubing (077.0952)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Suction system tubing A flexible, hollow, cylindrical device, typically made of synthetic material, used to connect a suction catheter to a collection bottle/canister, a collection canister/bottle to a regulator/suction pump, or to connect a series of collection bottles/canisters to increase to total capacity within a suction system. This device can come in rolls from which required lengths are cut, or in predetermined lengths with built-in connectors. 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 [?]
K153663 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

334330f5-fae5-489e-b0ac-ac34f7ac6f2c
July 06, 2018
3
October 14, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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