Duns Number:141668116
Device Description: Cylinder Roller Bag & Backpack — Single D/E Tank
Catalog Number
CSBD1Roller
Brand Name
Cylinder Roller Bag & Backpack — Single D/E Tank
Version/Model Number
CSBD1Roller
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
9d6259cd-b0f2-4536-aac1-71b3f76a9cad
Public Version Date
April 21, 2021
Public Version Number
4
DI Record Publish Date
July 31, 2018
Package DI Number
10848530087781
Quantity per Package
8
Contains DI Package
00848530087784
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |