Duns Number:080456871
Device Description: Reduced Heparin (Arterial Blood Sampler)
Catalog Number
9023RHSL
Brand Name
AirLife™
Version/Model Number
9023RHSL
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
OFP
Product Code Name
Anesthesia breathing circuit kit (adult & pediatric)
Public Device Record Key
d5891779-4f8e-4ace-8a7e-fc77d384cb33
Public Version Date
September 13, 2022
Public Version Number
1
DI Record Publish Date
September 05, 2022
Package DI Number
50190752155020
Quantity per Package
100
Contains DI Package
10190752155022
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 | 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 |