Duns Number:800082950
Device Description: TM6100, 1 each, 0.22µ Contamination tester, female luer lock inlet, male luer slip outlet. TM6100, 1 each, 0.22µ Contamination tester, female luer lock inlet, male luer slip outlet.TM6100, case of 10, includes 5cc syringe of TSB Media. TM6101, case of 10, includes 5cc syringe of FTM Media
Catalog Number
TM6100
Brand Name
QT Micro
Version/Model Number
Contamination Tester, luer slip outlet
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K950305,K950305,K950305,K950305
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
bf970ee9-cddb-4c77-83dc-8148b51e8315
Public Version Date
March 07, 2022
Public Version Number
5
DI Record Publish Date
March 10, 2017
Package DI Number
10854989006105
Quantity per Package
200
Contains DI Package
00854989006108
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bulk case