DEVICE: Avance (07323190166442)

Device Identifier (DI) Information

Avance
772003-00
In Commercial Distribution
772003
Mölnlycke Health Care AB
07323190166442
GS1

1
631770658 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
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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
Negative-pressure wound therapy tubing set A collection of sterile, flexible, plastic tubing and associated items (e.g., connectors, line clamp, negative pressure applicator pad, canister) intended to be used as part of a vacuum-assisted wound closure system; commonly known as negative pressure wound therapy (NPWT). It is designed to create an airtight connection between the open-cell foam dressing and drape at the wound site and the vacuum pump. The tubing allows negative pressure to be delivered to the wound site and provides a conduit to channel excess interstitial fluid, wound exudate, and infectious materials from the wound to the collection canister. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OMP negative pressure wound therapy Powered suction pump
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K161797 000
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Sterilization

Yes
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

d675f32d-f669-453d-bdd2-4f9da408e164
July 06, 2018
4
January 18, 2017
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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
07323190154395 10 07323190166442 In Commercial Distribution
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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
No
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Customer Contact

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No Customer Contact currently defined
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