Duns Number:878070325
Device Description: Patient Transportation PTB Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobi Patient Transportation PTB Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Gurney Sheet with Elastic at the Head and Foot, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.
Catalog Number
10-9030PTB
Brand Name
Bosma Enterprises
Version/Model Number
10-9030PTB
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
ef5a7d3b-85c4-4d56-bd40-93c59395de6f
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020281
Quantity per Package
20
Contains DI Package
00818634020284
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 |