Duns Number:039612668
Device Description: (1) ABSORBENT POWDER(4) ANTISEPTIC TOWELETTE(1) PLASTIC SCOOP(1) BIOHAZARD BAG 10 GALLON W (1) ABSORBENT POWDER(4) ANTISEPTIC TOWELETTE(1) PLASTIC SCOOP(1) BIOHAZARD BAG 10 GALLON WITH TIE(1) CPR PROTECTOR(1) DISPOSABLE FACE MASK WITH SHIELD(2) GERMICIDAL WIPE(3) HAND SANITIZER(1) INFECTION CONTROL GOWN(2) NITRILE GLOVES - PAIRS(2) PAPER TOWEL(1) BOUFFANT
Catalog Number
-
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
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
cd299a6c-1102-4d8a-a879-31bff33905e1
Public Version Date
May 26, 2022
Public Version Number
1
DI Record Publish Date
May 18, 2022
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 |