Duns Number:054326178
Device Description: Sage AirTAP LC 10 Pack Configuration
Catalog Number
7289
Brand Name
Sage AirTAP LC
Version/Model Number
7289
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMR
Product Code Name
DEVICE, TRANSFER, PATIENT, MANUAL
Public Device Record Key
4eab584a-8453-453c-acdf-3d140b9af0d0
Public Version Date
February 21, 2022
Public Version Number
4
DI Record Publish Date
April 20, 2020
Package DI Number
50618029720851
Quantity per Package
10
Contains DI Package
00618029720856
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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |