DEVICE: RENASYS GO (00040565127149)
Device Identifier (DI) Information
RENASYS GO
66021739
In Commercial Distribution
66021739
SMITH & NEPHEW MEDICAL LIMITED
66021739
In Commercial Distribution
66021739
SMITH & NEPHEW MEDICAL LIMITED
Clinician User Manual US Only
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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 system, battery-powered, reusable | A portable assembly of devices designed to treat hard-to-heal open wounds (e.g., traumatic and chronic) and diabetic/pressure ulcers with suction. It typically consists of a non-sterile battery-powered vacuum pump, an integrated disposable collection canister, and a shoulder bag for carrying during ambulation. It is connected to the patient with drainage tubing. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
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OMP | Negative Pressure Wound Therapy Powered Suction Pump |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K152163 | 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
47eea5d8-1905-4684-b525-ce2457f1cf51
July 06, 2018
3
December 01, 2016
July 06, 2018
3
December 01, 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 |
---|---|---|---|---|---|
05000223491451 | 25 | 00040565127149 | 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