DEVICE: RENASYS TOUCH (00040565126531)
Device Identifier (DI) Information
RENASYS TOUCH
66801274
In Commercial Distribution
66801274
SMITH & NEPHEW MEDICAL LIMITED
66801274
In Commercial Distribution
66801274
SMITH & NEPHEW MEDICAL LIMITED
RENASYS TOUCH 800ml Canister with Solidifier
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
20395 | Negative-pressure wound therapy system, electric, reusable |
An assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and an electrically-powered vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OMP | Negative Pressure Wound Therapy Powered Suction Pump |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K153209 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cfbfa635-2264-44a3-b275-125802927100
September 07, 2023
5
November 02, 2016
September 07, 2023
5
November 02, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30040565126532 | 5 | 00040565126531 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined