Duns Number:141588017
Device Description: LIFESHIELD LATEX-FREE 150 mL BURETTE SET, Convertible Pin, 77.5 Inch with 2 Prepierced Inj LIFESHIELD LATEX-FREE 150 mL BURETTE SET, Convertible Pin, 77.5 Inch with 2 Prepierced Injection Sites and OPTION-LOK SOLUSET MICRODRIP
Catalog Number
1272865
Brand Name
Lifeshield
Version/Model Number
1272865
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
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
b3f8c3a2-7a4d-403e-8437-bbfac7488321
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
20887787007187
Quantity per Package
20
Contains DI Package
10887787007180
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |