Duns Number:039612668
Device Description: "(1) ABSORBENT POWDER(4) ANTISEPTIC TOWELETTE(1) BAG WITH SCOOP(1) BIOHAZARD BAG(1) BOUFFA "(1) ABSORBENT POWDER(4) ANTISEPTIC TOWELETTE(1) BAG WITH SCOOP(1) BIOHAZARD BAG(1) BOUFFANT CAP(1) CPROTECTOR(1) GOWN(3) INSTANT HAND SANITIZER(2) NITRILE GLOVE 2(2) PAPER TOWEL(2) GERMICIDAL WIPE(1) DISPOSABLE FACE MASK WITH SHIELD"
Catalog Number
S-16500
Brand Name
Bloodborne Pathogen Kit - 19 Piece
Version/Model Number
S-16500
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)
-
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
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
90a4f562-5704-4d9c-9887-7ffb490cb3aa
Public Version Date
March 23, 2022
Public Version Number
4
DI Record Publish Date
February 22, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 2 |