Duns Number:040876183
Device Description: ArmGuard Classic Sled Kit - Includes 2 Standard Sleds (00811836030372) and 2 Bariatric Sle ArmGuard Classic Sled Kit - Includes 2 Standard Sleds (00811836030372) and 2 Bariatric Sleds (00811836030389), for use with ArmGuard Packs and accessories
Catalog Number
-
Brand Name
ArmGuard™
Version/Model Number
40004
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
-
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
42a666a0-b5cc-45ba-9763-74ebe202ef8a
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
May 17, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |