Duns Number:053146767
Device Description: Wall-mounted storage box provides storage and immediate availability for emergency-use ite Wall-mounted storage box provides storage and immediate availability for emergency-use items such as oxygen masks, resuscitator bags, airways, masks, filters, etc. (The storage box does not include these items.) Dimensions: 18" Length x 6" Width x 5-1/4" Depth.
Catalog Number
BE 4500-18D
Brand Name
BE 4500-18D Mask/Filter Storage Box
Version/Model Number
BE 4500-18D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
19abef01-cc18-4311-9a3b-3d8f92879e09
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 28, 2019
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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |