Duns Number:533108028
Catalog Number
15061-131-0004
Brand Name
PCA Lockbox 100 mL
Version/Model Number
15061-131-0004
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
-
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
K123049,K123049,K123049
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
b112187b-24cc-4df0-aa46-8aecf37c0068
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
27290109150028
Quantity per Package
12
Contains DI Package
17290109150021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cardboard box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |