S
S-Monovette® - 05.1104.100
Device Description
A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and a clot activator. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum 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: JKA
Device Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1675
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 04038917020190
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04038917125574
Package Quantity: 500
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04038917125574
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: 04038917199681
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