Duns Number:038838914
Device Description: Saljet 40 is a single use disposable polymer vial with a twist off top containing 30ml of Saljet 40 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. Forty vials per carton.
Catalog Number
-
Brand Name
Saljet
Version/Model Number
Saljet 40
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
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
K993969,K993969,K993969
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
b84a811d-f4be-4ec1-bada-957045c01495
Public Version Date
July 31, 2019
Public Version Number
2
DI Record Publish Date
September 21, 2018
Package DI Number
30188151000009
Quantity per Package
6
Contains DI Package
10188151000005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case