Duns Number:963236661
Device Description: 99% IPA bottle for use with the Firefly system
Catalog Number
-
Brand Name
Firefly IPA Bottle
Version/Model Number
40595
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 01, 2016
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
-
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
KDJ
Product Code Name
Set, Administration, For Peritoneal Dialysis, Disposable
Public Device Record Key
f6e9086d-8378-4744-9b4b-f0b19772fbb4
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
November 21, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |