Duns Number:103169095
Device Description: Airtime Small Bore Adapter, 25 Adapters per Bag. 12 bags of 25 Adapters per Case. (Ref: F Airtime Small Bore Adapter, 25 Adapters per Bag. 12 bags of 25 Adapters per Case. (Ref: Fisnar # 8001268, 14 gauge)
Catalog Number
-
Brand Name
Airtime Small Bore Adapter
Version/Model Number
ST14G
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JRJ
Product Code Name
Unit, Drying
Public Device Record Key
f4987102-8d1a-46ff-bef2-9b601cd72796
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
10843356102359
Quantity per Package
12
Contains DI Package
00843356102352
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 | 146 |