Duns Number:867288557
Device Description: Access Point is an accessory that enables wireless streaming to a computer for the Opal V2 Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
Catalog Number
-
Brand Name
Access Point V2C
Version/Model Number
APV2C
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
ISD
Product Code Name
Exerciser, Measuring
Public Device Record Key
d8b477bb-d33e-4c32-9a3c-ba8f56edc10c
Public Version Date
January 26, 2021
Public Version Number
1
DI Record Publish Date
January 18, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |