Duns Number:002348191
Device Description: 0.5 - Liter Hyperinflation Bag with Oxygen Tubing
Catalog Number
5401
Brand Name
HUDSON RCI
Version/Model Number
IPN060008
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
Yes
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
BZR
Product Code Name
Mixer, breathing gases, anesthesia inhalation
Public Device Record Key
1a043924-b97f-4c94-9c9f-3f3897849dac
Public Version Date
June 26, 2019
Public Version Number
1
DI Record Publish Date
June 18, 2019
Package DI Number
34026704656203
Quantity per Package
20
Contains DI Package
14026704656209
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |