Duns Number:879187821
Device Description: RELI® Safety Blood Collection Tube Holder - Orange
Catalog Number
SBCTH-Orange
Brand Name
RELI
Version/Model Number
SBCTH-Orange
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
K173279,K173279,K173279
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
ba42cfb4-68a8-47c9-a336-6f5ecef89379
Public Version Date
April 23, 2019
Public Version Number
2
DI Record Publish Date
January 07, 2019
Package DI Number
20386120007414
Quantity per Package
16
Contains DI Package
10386120007417
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 |