Duns Number:072656713
Device Description: Bolin Chest Seal valved chest dressing used for sealing open chest wounds and reducing the Bolin Chest Seal valved chest dressing used for sealing open chest wounds and reducing the risk of tension pneumothoraxl
Catalog Number
BCS01
Brand Name
Bolin Chest Seal
Version/Model Number
6
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
ae8a1068-ab10-4854-a19b-713a3fef8455
Public Version Date
January 08, 2021
Public Version Number
1
DI Record Publish Date
December 31, 2020
Package DI Number
00857048006286
Quantity per Package
10
Contains DI Package
00857048006132
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |