Duns Number:785952607
Device Description: 22MM FLEXTUBE BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE 22MM FLEXTUBE BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 1.6M
Catalog Number
-
Brand Name
22MM FLEXTUBE BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF
Version/Model Number
2010235
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
Yes
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
4774aa04-5cab-471d-8a67-a019229e05bb
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
October 14, 2021
Package DI Number
05030267160259
Quantity per Package
8
Contains DI Package
05030267160242
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |