Duns Number:600850213
Device Description: ThermoFlo 1 Filter with Elbow and #5 Mask
Catalog Number
-
Brand Name
ARC Medical
Version/Model Number
6126M5
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
-
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
OFP
Product Code Name
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Public Device Record Key
7b053b14-4137-4ded-a646-ac9275d69f8c
Public Version Date
September 03, 2021
Public Version Number
1
DI Record Publish Date
August 26, 2021
Package DI Number
10810050853931
Quantity per Package
50
Contains DI Package
00810050853934
Package Discontinue Date
-
Package Status
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 | 39 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |