Duns Number:751149311
Device Description: NV ACUCARE F1-0 FFM MED
Catalog Number
60707
Brand Name
AcuCare
Version/Model Number
F1-0
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
b31d1a14-c22a-4b0e-b564-c00ad2d4720f
Public Version Date
July 23, 2021
Public Version Number
3
DI Record Publish Date
February 27, 2018
Package DI Number
00619498002719
Quantity per Package
20
Contains DI Package
00619498607075
Package Discontinue Date
-
Package Status
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 | 54 |
2 | A medical device with a moderate to high risk that requires special controls. | 841 |