Duns Number:023904428
Device Description: Specimen Container for Pneumatic Tube Systems 120 mL (4 oz.) Screw Cap Sterile
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-9542
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
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
eb76b71a-4651-470c-af66-f919bce4733f
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
40612479150612
Quantity per Package
300
Contains DI Package
20612479197521
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |