Duns Number:595156263
Device Description: Life2000 Compressor
Catalog Number
-
Brand Name
Life2000
Version/Model Number
MS-01-0093
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTI
Product Code Name
Compressor, air, portable
Public Device Record Key
863e1f04-634c-4205-a2a2-f726dce3b037
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
00887761981645
Quantity per Package
1
Contains DI Package
00887761978072
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 131 |