Duns Number:084527241
Catalog Number
6988BLW-12
Brand Name
CVR, BILATERAL WINGED CHEST PAD
Version/Model Number
6977-771
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
Yes
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
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
ab54a607-22c7-4867-bf6f-b8d0f40787fe
Public Version Date
September 19, 2022
Public Version Number
3
DI Record Publish Date
June 24, 2019
Package DI Number
10842430110679
Quantity per Package
12
Contains DI Package
00842430110672
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1076 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |