Tube-Segment-Opener - 95.1000
Device Description
A sampling device intended to be used for extracting a blood specimen from a blood donor bag tubing segment for analysis and/or other investigation (e.g., blood grouping, cross matching). It typically consists of a needle surrounded by plastic housing designed so that the blood-filled tubing segment may be inserted into the housing, pierced by the needle, and a sample manually extracted without exposing the user to either the blood or the needle. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LXG
Device Name: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.2050
Third Party Flag: N
Medical Specialty: CH
Device Identifiers
Device Id: 04038917167079
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
Device Id: 04038917084949
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
