Duns Number:830864406
Device Description: TFP Breathing Filter
Catalog Number
-
Brand Name
Spiro-Filter
Version/Model Number
D1010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2020
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
Yes
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
K884465,K884465,K884465
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
6699d0cc-556a-4ad4-b8fc-a94da0fa2b0d
Public Version Date
September 24, 2020
Public Version Number
5
DI Record Publish Date
October 11, 2016
Package DI Number
00855784004085
Quantity per Package
2
Contains DI Package
00855784004078
Package Discontinue Date
August 28, 2020
Package Status
Not 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |