Duns Number:060944361
Device Description: The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Catalog Number
80016-005
Brand Name
ASSURE, Garment, Style B, Size 5
Version/Model Number
80016-005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
P200037,P200037,P200037,P200037
Product Code
MVK
Product Code Name
Wearable Automated External Defibrillator
Public Device Record Key
64622f6b-8261-4f3b-bcce-c6a774fcae31
Public Version Date
January 12, 2022
Public Version Number
2
DI Record Publish Date
November 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 3 | A medical device with high risk that requires premarket approval | 21 |