Duns Number:092673953
Device Description: Anesthesia Circuit, Adult, 108" Expandable, Parallel Wye w/Port and Cap, GSE, In-line Mini Anesthesia Circuit, Adult, 108" Expandable, Parallel Wye w/Port and Cap, GSE, In-line Mini HMEF, 3L Latex Free Breathing Bag, Large Adult Mask, 10' suction tubin, 10' X .050 GSL w/ Swivel Elbow Yankaues,
Catalog Number
-
Brand Name
Anesthesia Circuit
Version/Model Number
9691
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
c01afbd5-4857-49ae-8b4a-593de0bb206c
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
October 08, 2021
Package DI Number
10709078013178
Quantity per Package
10
Contains DI Package
00709078013171
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |