Duns Number:006426316
Device Description: BLISTER KIT
Catalog Number
200724
Brand Name
Mueller Blister Kit
Version/Model Number
200724
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAE
Product Code Name
Dressing, wound, hydrogel without drug and/or biologic
Public Device Record Key
a8602976-48c0-41a9-9108-f2ad7c3eb8ba
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
20074676207241
Quantity per Package
12
Contains DI Package
00074676207247
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BLISTER PACK
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 148 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |