Duns Number:062084215
Device Description: HBO CHMBER,32IN,PNMTC,ENGLISH,BLUE
Catalog Number
-
Brand Name
Sechrist Industries, Inc.
Version/Model Number
3200-00
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
CBF
Product Code Name
Chamber, Hyperbaric
Public Device Record Key
4bfa60b4-8824-4009-bdd4-0f442ec816e7
Public Version Date
February 10, 2020
Public Version Number
1
DI Record Publish Date
February 01, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 169 |