Duns Number:878070325
Device Description: Patient Transportation BAL Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobi Patient Transportation BAL Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Wide Gurney Sheet with Elastic at the Head and Foot, 40x80 XL Lift Sheet, and STAT-BLOC Disposable Pillowcase.
Catalog Number
10-9030BAL
Brand Name
Bosma Enterprises
Version/Model Number
10-9030BAL
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
5d273a0f-58be-4e53-a904-eeff200d091a
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020274
Quantity per Package
16
Contains DI Package
00818634020277
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 |