Duns Number:099674145
Device Description: Critical Measure Insert
Catalog Number
20-02-0152
Brand Name
Allied Healthcare Products Inc.
Version/Model Number
13622
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
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
19501d66-7a40-4e90-b96e-3981d22c741f
Public Version Date
January 08, 2021
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
40026072002474
Quantity per Package
12
Contains DI Package
00026072002476
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1099 |