DEVICE: Renasys (00040565127248)

Device Identifier (DI) Information

Renasys
66020799
In Commercial Distribution
66020799
Smith & Nephew, Inc..
00040565127248
GS1

1
827731451 *Terms of Use
Renasys Soft Port Stand Alone
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Wound dressing kit, medicated, sterile A collection of sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.
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FDA Product Code

[?]
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 [?]
K142979 000
No CLOSE

Sterilization

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

[?]
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

ce5978d9-5645-4cdc-b28a-bba5339b3729
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30040565127249 5 00040565127248 In Commercial Distribution Case
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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