Duns Number:008124539
Device Description: Mucus Specimen Trap; Leak Proof Transport Cap (40cc)
Catalog Number
-
Brand Name
Mucus Specimen Trap
Version/Model Number
32270
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYZ
Product Code Name
Trap, Sterile Specimen
Public Device Record Key
03613e79-01c1-40cb-8698-c1870b557619
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
April 22, 2021
Package DI Number
00840117310384
Quantity per Package
50
Contains DI Package
00840117310377
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |