Duns Number:879187821
Device Description: RELI® Blood Collection Needle 22G x 1”, Sterile
Catalog Number
BCN-R22G101
Brand Name
RELI
Version/Model Number
BCN-R22G101
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
K090426,K090426,K090426
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
03fbe9b8-886d-452f-afa7-d186b6aa8c3b
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
November 30, 2018
Package DI Number
20386120007995
Quantity per Package
40
Contains DI Package
10386120007998
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |