S
S-Monovette® - 04.1932.001
Device Description
A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., lithium heparin, ethylenediaminetetraacetic acid (EDTA)] and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PJE
Device Name: Blood/Plasma Collection Device For Dna Testing
Device Class: 2
Physical State: Blood collection device
Definition: A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The blood is drawn in the tube to be transported to the laboratory for clinical DNA testing.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Whole blood/ plasma for in vitro diagnostics
Regulation Number: 862.1675
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 04038917028868
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04038917134521
Package Quantity: 500
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04038917134521
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 04038917207133
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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