Duns Number:867673159
Device Description: RespiratoryRegulators Product Description: Rgltr Mini870, (111842),0-15L,1ea20cs
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
18302GMN-MC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2019
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
CAN
Product Code Name
REGULATOR, PRESSURE, GAS CYLINDER
Public Device Record Key
d7cf6f0a-f2a0-4047-ba27-da8d1edd309f
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
50822383984877
Quantity per Package
20
Contains DI Package
00822383984872
Package Discontinue Date
June 22, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3783 |
2 | A medical device with a moderate to high risk that requires special controls. | 832 |