Duns Number:878070325
Device Description: Accelerate-OR SPO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag ( Accelerate-OR SPO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), and 20x29 Disposable Pillowcase (3).
Catalog Number
10-8020SPO
Brand Name
Bosma Enterprises
Version/Model Number
10-8020SPO
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PWU
Product Code Name
Clean-Up Kit
Public Device Record Key
a54bb285-c546-4752-aa61-f302e98ded42
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020694
Quantity per Package
12
Contains DI Package
00818634020697
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 | 72 |