Duns Number:878070325
Device Description: Ambulance Pack PTL Kit; Each Kit Includes STAT-BLOC Disposable Antimicrobial Impervious Fi Ambulance Pack PTL Kit; Each Kit Includes STAT-BLOC Disposable Antimicrobial Impervious Fitted Gurney Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.
Catalog Number
10-9030PTL
Brand Name
Bosma Enterprises
Version/Model Number
10-9030PTL
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
235c334d-7432-4c30-ab69-c8747792aaf7
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020236
Quantity per Package
20
Contains DI Package
00818634020239
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 |