Duns Number:025460908
Device Description: SPACER,RIGID,RECLOSABLE BAG
Catalog Number
HCSA100
Brand Name
Medline
Version/Model Number
HCSA100
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
CAF
Product Code Name
Nebulizer (direct patient interface)
Public Device Record Key
712b00aa-5aae-4bd4-aa2b-395f8dc39f39
Public Version Date
April 09, 2021
Public Version Number
1
DI Record Publish Date
April 01, 2021
Package DI Number
40884389131634
Quantity per Package
10
Contains DI Package
10884389131633
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |