Duns Number:051798999
Device Description: TUBE PACK 1/4 ID X 4
Catalog Number
-
Brand Name
NA
Version/Model Number
19932
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 14, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
BOTTLE, COLLECTION, VACUUM
Public Device Record Key
bfa4f2a4-a248-4460-a71b-2f441ee5b089
Public Version Date
October 26, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2015
Package DI Number
20650862199325
Quantity per Package
20
Contains DI Package
00650862199321
Package Discontinue Date
July 14, 2020
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 161 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |