Duns Number:002348191
Device Description: ASHERMAN CHEST SEAL
Catalog Number
849100
Brand Name
RUSCH
Version/Model Number
IPN029670
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)
Yes
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
K942757,K942757,K942757,K942757
Product Code
MGP
Product Code Name
DRESSING, WOUND AND BURN, OCCLUSIVE
Public Device Record Key
8bd85442-5254-4cc5-9716-33eea0a021e9
Public Version Date
August 31, 2022
Public Version Number
6
DI Record Publish Date
July 24, 2019
Package DI Number
24026704662757
Quantity per Package
10
Contains DI Package
14026704662750
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |