Duns Number:055363428
Device Description: MASK, QUADRALITE, MEDIUM ADULT, ANAESTHETIC WITH YELLOW CUSHION AND HOOK RING, 22F (10/CAS MASK, QUADRALITE, MEDIUM ADULT, ANAESTHETIC WITH YELLOW CUSHION AND HOOK RING, 22F (10/CASE)
Catalog Number
-
Brand Name
PATIENT CIRCUITS
Version/Model Number
712-000007-10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111473
Product Code
CBK
Product Code Name
VENTILATOR, CONTINUOUS, FACILITY USE
Public Device Record Key
0db8b233-8047-4dcd-9fb1-66f00e034a49
Public Version Date
June 09, 2022
Public Version Number
3
DI Record Publish Date
November 29, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |