Duns Number:819753190
Device Description: MediEvac+ is variable control medical suction equipment powered from a vacuum source used MediEvac+ is variable control medical suction equipment powered from a vacuum source used for vacuum regulation.MediEvac+ is intended for suction of body liquids from any part of a patient's body during surgical operations, resuscitation, chest and gastritic drainage, etc.The product is not intended to be powered from:• a venturi vacuum source• a pressure gas source.The product is not intended for:• field use• direct use during thoracic drainage
Catalog Number
-
Brand Name
ME+1000 _ DS _ G1/2 G
Version/Model Number
0735101US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDP
Product Code Name
Regulator, Vacuum
Public Device Record Key
2fe22d0a-5b91-41e7-b208-8ad5168137f1
Public Version Date
February 25, 2021
Public Version Number
1
DI Record Publish Date
February 17, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 96 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |