Duns Number:103056420
Device Description: BATTERY PACK
Catalog Number
-
Brand Name
MicroAire®
Version/Model Number
7500-620
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MOQ
Product Code Name
Battery, Replacement, Rechargeable
Public Device Record Key
56ecc341-517f-42b5-ae0b-4283ef534cd1
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 17, 2022
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 | 756 |
2 | A medical device with a moderate to high risk that requires special controls. | 190 |