Duns Number:187502109
Device Description: Fluid Management System, Integrated Tube Set, Do not use if package is damaged, Keep dry, Fluid Management System, Integrated Tube Set, Do not use if package is damaged, Keep dry, Keep away from sunlight, Keep away from heat and radioactive sources
Catalog Number
0502-200-000A
Brand Name
Fluid Safe
Version/Model Number
0502200000A
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
-
Product Code
HIG
Product Code Name
INSUFFLATOR, HYSTEROSCOPIC
Public Device Record Key
19b693b0-202b-404a-9984-2a413304cb71
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 14, 2016
Package DI Number
37613327055840
Quantity per Package
10
Contains DI Package
07613327055849
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |