Duns Number:080456871
Device Description: Patient Circuit, 22mm, SPU
Catalog Number
18221-101
Brand Name
LTV
Version/Model Number
18221-101
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"
-
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
K101643,K101643
Product Code
CBK
Product Code Name
Ventilator, continuous, facility use
Public Device Record Key
93aaecbe-68d4-46b5-8369-f8b6020c9951
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
March 26, 2021
Package DI Number
50190752183863
Quantity per Package
10
Contains DI Package
10190752183865
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |