Duns Number:600111512
Device Description: Microstream Advance Hook and loop strap
Catalog Number
-
Brand Name
Microstream Advance
Version/Model Number
012542
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093388,K093388
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
71de96e0-6d58-4ac3-a52b-c299e4b93a73
Public Version Date
April 28, 2022
Public Version Number
3
DI Record Publish Date
March 07, 2019
Package DI Number
40884521520746
Quantity per Package
25
Contains DI Package
30884521520749
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 154 |