Duns Number:002348191
Device Description: CONCHAPAK Sterile Water, 1650 mL with Minimal Compliance CONCHA COLUMN
Catalog Number
385-40
Brand Name
HUDSON RCI
Version/Model Number
IPN044288
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
K993355,K993355
Product Code
BTT
Product Code Name
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Public Device Record Key
d4fb8648-234d-4c0b-bf27-b6dc91f56846
Public Version Date
November 22, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
14026704597632
Quantity per Package
6
Contains DI Package
04026704597635
Package Discontinue Date
September 30, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
| 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 |