Duns Number:625272232
Device Description: PermaLife Cell Culture bag, 30ml, with SCD Tubing
Catalog Number
PL30T
Brand Name
PermaLife
Version/Model Number
PL30T
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
K021702,K021702
Product Code
LPZ
Product Code Name
Container, Frozen Donor Tissue Storage
Public Device Record Key
556ef6ed-1f75-444e-b934-0bef0a60b12c
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
November 15, 2021
Package DI Number
20816203023593
Quantity per Package
25
Contains DI Package
10816203023596
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |