Duns Number:106712748
Catalog Number
-
Brand Name
Level 1
Version/Model Number
X-36
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
BK860023,BK860023,BK860023
Product Code
KZL
Product Code Name
DEVICE, WARMING. BLOOD AND PLASMA
Public Device Record Key
24ed5cdd-9111-400a-8613-52ce6b0ebf8e
Public Version Date
August 17, 2018
Public Version Number
4
DI Record Publish Date
October 11, 2016
Package DI Number
10695085403609
Quantity per Package
40
Contains DI Package
30695085403603
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |